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NCTID: NCT05554003

Title: Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study 
Study Summary: Study design and rationale: Neuroendocrine neoplasms (NENs ) represent a heterogeneous group of malignancies, which differ in terms of behavio r and prognosis. Most of t hem are advanced at diagnosis t herefore systemic treatment is proposed. While over the last years many advanced have been made especially in terms of molecular targeted therapies (MTA) like everolimus and sunitinib, chemotherapy i n NENs still represents a controversial question. Temozolomide has been reported to be active alone or in combination with other drugs in neuroendocrine neoplasms (NENs) from different origin. So far there is not universal agreement on the right setting an d way of administration of this therapy. Objective: This is a multicentric phase II prospective interventional study to evaluate the clinical features of patients, who are judged unfit for systemic treatments, consecutively treated with a metronomic Temozolomide chemotherapy schedule in Italian centers with expertise in NEN and to explore also the methylation status of O6-methylguanine-DNA-methyltransferase (MGMT) and the polymorphism of thymidylate synthase (TS) by pyrosequencing in those patients of which tissues were available. This study will allow a better understanding of the role of metronomic temozolomide chemotherapy in NENs patients and help clinicians in answering some of the outstanding questions on their management. Method: Prospective analysis of clinical data of patients unfit for chemotherapy consecutively treated with metronomic temozolomide regimen in Italian centers with expertise in clinical and research NEN activity, for one year from the start of the accrual. Planning of study: Data from NENs patients of any age treated at these centers will be retrieved by searching the hospital information system and analysed. Eligible study population: Patients with histological diagnosis of low grade advanced NEN treated unfit for systemic treatments, for one year from the start of the accrual. Endpoints and evaluation parameters:  Description of efficacy and toxicity of Temozolomide regimen in patients with advanced NENs with different primary sites unfit for systemic treatment and explored the pote ntial correlation with clinical/biological factors. 
Sponsor: European Institute of Oncology 
Intervention: Temozolomide capsule 
Start Date: 2022-01-14 
Last Updated: 2022-09-26 
Number of Patients: 46 
Recruitment Status: RECRUITING 
Condition: Neuroendocrine Tumors 

NCTID: NCT04987203

Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma 
Study Summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). 
Sponsor: AVEO Pharmaceuticals, Inc. 
Intervention: Tivozanib 
Start Date: 2021-09-09 
Last Updated: 2023-11-28 
Number of Patients: 326 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Carcinoma 

NCTID: NCT02167490

Title: Sentinel Node Vs Observation After Axillary Ultra-souND 
Study Summary: The hypothesis of this trial are that:  * avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients * pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden.  The aims of this prospective randomized study are:  * to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared * to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status * to verify whether, in presence of a negative preoperative axillary assessment, the patients’ quality of life can be improved by a less invasive surgical procedure. 
Sponsor: European Institute of Oncology 
Intervention: Arm 1: sentinel node biopsy 
Start Date: 2012-01 
Last Updated: 2023-02-17 
Number of Patients: 1560 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Early Stage Breast Carcinoma 

NCTID: NCT03939156

Title: Patients’ Preferences for Adjuvant Endocrine Therapy in Early Breast Cancer 
Study Summary: Preference studies reveal how individuals trade-off the potential benefits, harms and inconveniences of a treatment by determining the minimum benefits they judge sufficient to make the treatment worthwhile.  They are especially relevant to adjuvant therapies where individuals must weigh up modest survival benefits only realized in time by no recurrence of their cancer with side effects predominantly experienced whilst on the treatment.  Previously it was reported, for example, that over 50% of women who had adjuvant chemotherapy for early breast cancer judged a 1% improvement in 5 year survival rates sufficient to make it worthwhile.  Larger survival benefits were required for longer duration adjuvant hormonal therapy where over 50% of women required at least 5% improvement in 5 year survival rates to make it worthwhile. 
Sponsor: European Institute of Oncology 
Intervention: Completion of questionnaires 
Start Date: 2018-06-05 
Last Updated: 2023-06-28 
Number of Patients: 450 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00369850

Title: Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98 
Study Summary: RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.  PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: laboratory biomarker analysis 
Start Date: 2004-05 
Last Updated: 2012-07-27 
Number of Patients: 458 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02460068

Title: A Study of Fotemustine(FTM) Vs FTM and Ipilimumab (IPI) or IPI and Nivolumab in Melanoma Brain Metastasis 
Study Summary: This Phase 3, open-label, triple arm study aims to evaluate the overall survival (OS) of fotemustine versus the combination of ipilimumab and fotemustine or the combination of Ipilimumab and nivolumab in patients with metastatic melanoma with brain metastasis. 
Sponsor: Italian Network for Tumor Biotherapy Foundation 
Intervention: Fotemustine 
Start Date: 2012-12 
Last Updated: 2015-06-02 
Number of Patients: 168 
Recruitment Status: UNKNOWN 
Condition: Brain Metastases 

NCTID: NCT01248806

Title: Continuous Observation of Smoking Subject 
Study Summary: The purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer. 
Sponsor: European Institute of Oncology 
Intervention: Low dose CT scan 
Start Date: 2004-10 
Last Updated: 2022-05-13 
Number of Patients: 5203 
Recruitment Status: COMPLETED 
Condition: Subjects at High Risk of Lung Cancer Due to Smoking 

NCTID: NCT01733706

Title: Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling. 
Study Summary: The aim of this study is the evaluation of early smoking reduction or cessation by means of no nicotine electronic cigarette added to standard counselling. 
Sponsor: European Institute of Oncology 
Intervention: No nicotine electronic cigarette 
Start Date: 2011-06 
Last Updated: 2017-02-09 
Number of Patients: 75 
Recruitment Status: COMPLETED 
Condition: Cancer 

NCTID: NCT00343616

Title: Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98 
Study Summary: RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer.  PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: cognitive assessment 
Start Date: 2005-04 
Last Updated: 2012-07-27 
Number of Patients: 135 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01935154

Title: Efficacy Study of Vx001 Vaccine in NSCLC Patients 
Study Summary: Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A*0201 positive patients with TERT expressing tumors will be included.  The objective of the trial is survival rate at 12 months. 
Sponsor: Vaxon Biotech 
Intervention: Vx-001 
Start Date: 2012-08 
Last Updated: 2019-06-19 
Number of Patients: 221 
Recruitment Status: COMPLETED 
Condition: Non-small Cell Lung Cancer Metastatic 

NCTID: NCT04679454

Title: Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer 
Study Summary: This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients. 
Sponsor: European Institute of Oncology 
Intervention: Phase I 
Start Date: 2021-07-31 
Last Updated: 2021-08-25 
Number of Patients: 79 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT06059859

Title: Impact of Augmented Reality During Robot-assisted Radical Prostatectomy 
Study Summary: Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease. 
Sponsor: European Institute of Oncology 
Intervention: Augmented reality robot-assited radical prostatectomy 
Start Date: 2022-01-01 
Last Updated: 2023-09-29 
Number of Patients: 318 
Recruitment Status: RECRUITING 
Condition: Prostatic Neoplasm 

NCTID: NCT05095675

Title: Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back 
Study Summary: Breast cancer accounts for 28% of all cancer cases in Europe (“WHO,” 2018). Coping with breast cancer is becoming an increasingly burdensome socio-economic challenge, partly due to the increasing incidence registered in the last years, which is occurring despite continuous advances in medicine. This said, mortality rate has decreased significantly as 5-year survival rate has risen from 75% to 90% (“Breast Cancer Research Foundation,” 2016). For these reasons the number of cancer survivors has grown, with important effects on quality of life even years after the end of treatments.  The process of successful adaptation to breast cancer and the various accompanying stressors can be conceptually defined as the person’s resilience. Resilience is a complex construct that can be defined on different levels: an individual’s potential (capacity to engage in adaptive coping processes), a process (adaptive reactions to adversity), and an outcome (the final state achieved as the result of coping).  While theoretical contributions regarding resilience models in medical settings have been advanced (Deshields et al., 2016), to date no one has tested the integrated contributing role of multiple psychological, biological and functional variables in predicting the patient’s ability to bounce back from the stressful life event of being diagnosed with breast cancer. Resilience is going to be measured through a data-driven method (computation of resilience index on the basis of retrospective data) and through a psychometric method (various domains of resilience through questionnaires).  There is a growing need for novel strategies to improve the understanding and the capacity to predict resilience of women to the variety of stressful experiences.  BOUNCE European Project (H2020 European Project “Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back”; Grant Agreement Nr: 777167) will bring together modelling, medical, and social sciences experts to advance current knowledge on the dynamic nature of resilience as it relates to improved quality of life.  The broad and general objective of the BOUNCE project is to build a quantitative mathematical model of factors associated with optimal adjustment capacity to cancer. The investigators will collect biomedical status (BMS), the psychosocial status (PSS) and the functional status (FUS) of breast cancer patients that literature demonstrated to be predictive of patients’ capacity to bounce back during the highly stressful treatment and recovery period following diagnosis of breast cancer. The overarching goal of the model is to understand which factors predict optimal adjustment to breast cancer and which combination of factors undermine adjustment. This would allow early identification of women at risk for which it is better to intervene through a personalised psychological support.  Funding: The BOUNCE Project “Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE back” has received funding from the European Union’s Horizon 2020 research and innovation programme, Project type: H2020 - SCI-2017-CNECT-2; Project type: H2020 - SCI-2017-CNECT-2; Grant Agreement Nr: 777167. 
Sponsor: European Institute of Oncology 
Intervention: psychological questionnaires 
Start Date: 2018-12-06 
Last Updated: 2023-06-28 
Number of Patients: 660 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT03712956

Title: CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER 
Study Summary: A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.  The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.  Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses. 
Sponsor: European Institute of Oncology 
Intervention: Caelyx® 
Start Date: 2016-03-25 
Last Updated: 2023-09-21 
Number of Patients: 63 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05649943

Title: Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment 
Study Summary: Italian multicenter study, will enroll ~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.  After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator’s choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy. 
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 
Intervention: APA + ADT 
Start Date: 2023-03-01 
Last Updated: 2023-04-24 
Number of Patients: 566 
Recruitment Status: RECRUITING 
Condition: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) 

NCTID: NCT05023967

Title: Metformin and Nightly Fasting in Women With Early Breast Cancer 
Study Summary: This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight. 
Sponsor: M.D. Anderson Cancer Center 
Intervention: Biospecimen Collection 
Start Date: 2023-04-04 
Last Updated: 2023-06-23 
Number of Patients: 120 
Recruitment Status: RECRUITING 
Condition: Anatomic Stage I Breast Cancer AJCC v8 

NCTID: NCT01281787

Title: PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer 
Study Summary: The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative period. 
Sponsor: European Institute of Oncology 
Intervention: Metoprolol 
Start Date: 2008-04 
Last Updated: 2014-06-18 
Number of Patients: 320 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT01198522

Title: Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients 
Study Summary: Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact on the survival of patients. Even with the application of more potent gemcitabine-based regimens, survival of more than 1 year is uncommon for advanced disease. Accordingly, there is substantial unmet needs for the improvement of treatment options. The combination and simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved anti-cancer efficacy, based on preliminary clinical and strong preclinical data.  The primary purpose of this Phase I study is to define a safe and potentially more active treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced pancreatic cancer patients. Also, early signs of anticancer responses of the L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine monotherapy). 
Sponsor: Philogen S.p.A. 
Intervention: L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine 
Start Date: 2007-06 
Last Updated: 2022-04-15 
Number of Patients: 28 
Recruitment Status: TERMINATED 
Condition: Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection 

NCTID: NCT05501886

Title: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) 
Study Summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. 
Sponsor: Celcuity, Inc. 
Intervention: Gedatolisib 
Start Date: 2022-09-30 
Last Updated: 2023-08-01 
Number of Patients: 701 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00066807

Title: Premenopausal Endocrine Responsive Chemotherapy Trial 
Study Summary: The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial <math display="block">recommended option</math>. The trial was terminated early due to poor accrual. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: chemotherapy 
Start Date: 2003-08 
Last Updated: 2016-10-28 
Number of Patients: 29 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT03762447

Title: A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors 
Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments. 
Sponsor: Incyte Corporation 
Intervention: INCB086550 
Start Date: 2018-12-10 
Last Updated: 2023-11-29 
Number of Patients: 138 
Recruitment Status: COMPLETED 
Condition: Solid Tumors 

NCTID: NCT00544219

Title: PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone 
Study Summary: RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment.  PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: rituximab 
Start Date: 2007-09 
Last Updated: 2019-05-15 
Number of Patients: 156 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT04312737

Title: Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus 
Study Summary: The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples. 
Sponsor: Hiantis Srl 
Intervention: Self-Collecting Devices 
Start Date: 2020-07-16 
Last Updated: 2023-01-06 
Number of Patients: 600 
Recruitment Status: COMPLETED 
Condition: Cervical Intraepithelial Neoplasia Grade 2/3 

NCTID: NCT01055522

Title: Clinical Study Phase II of L19IL2 in Combination With Dacarbazine in Patients With Metastatic Melanoma 
Study Summary: This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma.  The study is divided in two parts: a phase IIa part, designed to establish the recommended dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as well as to determine the preliminary tolerability profile; the second phase IIb part evaluates the objective response rate (ORR) including a randomized study with a fixed dose of Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa. 
Sponsor: Philogen S.p.A. 
Intervention: Arm 1: L19IL2 + Dacarbazine 
Start Date: 2008-06 
Last Updated: 2014-02-25 
Number of Patients: 102 
Recruitment Status: TERMINATED 
Condition: Metastatic Melanoma 

NCTID: NCT02169271

Title: Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules 
Study Summary: This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients with subsolid lung nodules. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Aspirin 
Start Date: 2014-11-21 
Last Updated: 2020-05-21 
Number of Patients: 109 
Recruitment Status: COMPLETED 
Condition: Current Smoker 

NCTID: NCT00951379

Title: Pioglitazone for Oral Premalignant Lesions 
Study Summary: The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Pioglitazone hydrochloride 
Start Date: 2010-02 
Last Updated: 2016-04-06 
Number of Patients: 52 
Recruitment Status: TERMINATED 
Condition: Oral Leukoplakia 

NCTID: NCT01446900

Title: R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma 
Study Summary: The objective of this study is to confirm the efficacy of the association of R-2cda in patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab alone in increasing and prolonging the duration of the response. 
Sponsor: European Institute of Oncology 
Intervention: Rituximab 
Start Date: 2011-01 
Last Updated: 2018-01-31 
Number of Patients: 25 
Recruitment Status: TERMINATED 
Condition: Chronic Lymphocytic Leukaemia 

NCTID: NCT00066703

Title: Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.  PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: exemestane 
Start Date: 2003-11-03 
Last Updated: 2022-11-17 
Number of Patients: 2672 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01968200

Title: Prevention of Anthracycline-induced Cardiotoxicity 
Study Summary: Anthracycline based anti-tumoral therapies are know to develop cardiac damage that could also lead to heart failure. Monocentric studies proved that a treatment with ACE inhibitors (ACEi) and betablockers (BB) during the first elevation of cardiac troponin is able to reduce the incidence of heart failure (HF).  ICOS-ONE trial is a multicenter randomized trial comparing two therapeutic strategies. The main objective is to assess whether enalapril started concomitantly to AC-containing treatments, can prevent cardiac toxicity more effectively than when enalapril is prescribed to selected patients showing laboratory evidences of injury after chemotherapy, during follow-up visits in 268 patients. 
Sponsor: European Institute of Oncology 
Intervention: Enalapril 
Start Date: 2012-12 
Last Updated: 2023-06-28 
Number of Patients: 268 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cancer 

NCTID: NCT00970983

Title: Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma 
Study Summary: The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based. 
Sponsor: European Institute of Oncology 
Intervention: quadrantectomy and axillary dissection 
Start Date: 1998-03 
Last Updated: 2011-11-29 
Number of Patients: 532 
Recruitment Status: COMPLETED 
Condition: Breast Carcinoma 

NCTID: NCT01849133

Title: Randomized Trial on Intraoperative Radiotherapy Full Dose Vs External Radiotherapy 
Study Summary: The purpose of this study is to investigate the efficacy of exclusive intraoperative radiation therapy after conserving surgery in early-stage breast cancer compared with whole breast radiotherapy. The primary outcome was the rate of ipsilateral true recurrence ( any recurrence at or close to primary tumor bed) and new ipsilateral tumors ( any recurrence occurring in quadrants other than the previous one) and the recurrence free survival. 
Sponsor: European Institute of Oncology 
Intervention: external fractionated radiotherapy 
Start Date: 2000-11 
Last Updated: 2013-05-08 
Number of Patients: 1305 
Recruitment Status: COMPLETED 
Condition: Carcinoma Breast 

NCTID: NCT03049189

Title: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients 
Study Summary: The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). 
Sponsor: ITM Solucin GmbH 
Intervention: 177Lu-edotreotide PRRT 
Start Date: 2017-02-02 
Last Updated: 2023-08-22 
Number of Patients: 309 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Neuroendocrine Tumors 

NCTID: NCT02093962

Title: Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer 
Study Summary: The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer. 
Sponsor: Threshold Pharmaceuticals 
Intervention: TH-302 combination with pemetrexed 
Start Date: 2014-06 
Last Updated: 2021-03-25 
Number of Patients: 265 
Recruitment Status: TERMINATED 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT01058538

Title: A Dose Finding Pharmacokinetic Study of the Tumour-targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein in Patients With Advanced Solid Tumours 
Study Summary: This is a Phase I/II study for patients with solid tumors and renal cell carcinoma (RCC; for the Phase II part). L19-IL2 is a tumor targeted immunocytokine constituted of a single chain Fragment variable (scFv) format directed against the ED-B domain of fibronectin, one of the most important markers for neoangiogenesis, and the human cytokine interleukin-2 (IL2). 
Sponsor: Philogen S.p.A. 
Intervention: L19IL2 
Start Date: 2005-11 
Last Updated: 2014-02-25 
Number of Patients: 33 
Recruitment Status: COMPLETED 
Condition: Advanced Solid Tumours 

NCTID: NCT01379989

Title: INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer 
Study Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients. 
Sponsor: Mario Negri Institute for Pharmacological Research 
Intervention: Carboplatin 
Start Date: 2011-06 
Last Updated: 2022-02-09 
Number of Patients: 617 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT04788849

Title: Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples 
Study Summary: The “Extended VALHUDES” study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the “Belgian VALHUDES”, of HPV testing using BD Onclarity on samples collected using Copan’s devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSponge™. 
Sponsor: University of Milano Bicocca 
Intervention: BD Onclarity™ HPV assay 
Start Date: 2021-03-08 
Last Updated: 2021-04-27 
Number of Patients: 300 
Recruitment Status: UNKNOWN 
Condition: Cervical Intraepithelial Neoplasia Grade 2/3 

NCTID: NCT00072293

Title: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases 
Study Summary: RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.  PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Axillary lymph node dissection 
Start Date: 2001-12 
Last Updated: 2018-01-23 
Number of Patients: 931 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00321893

Title: Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer 
Study Summary: RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.  PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Budesonide 
Start Date: 2006-01 
Last Updated: 2016-01-25 
Number of Patients: 225 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT00022516

Title: Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer 
Study Summary: This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Cyclophosphamide 
Start Date: 2000-11 
Last Updated: 2016-09-16 
Number of Patients: 1086 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01283945

Title: Study of Oral Lucitanib (E-3810), a Dual VEGFR-FGFR Tyrosine Kinase Inhibitor, in Patients With Solid Tumors 
Study Summary: Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two most relevant players in tumor angiogenesis and simultaneously targeting proliferation in FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2, 3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make it an attractive candidate for development in humans.  This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally, once daily, on a continuous schedule over the initial 28-day cycle.  Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics and antitumour activity of Lucitanib, given as a single agent to adult patients with advanced solid tumours.  The study consists of two phases, a dose escalation phase followed by a dose-expansion phase at the identified Recommended Dose (RD). Eligible patients have histologically or cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or 11q 12-14 amplification, assessed by FISH or CGH array, or “sensitive” to antiangiogenic treatment. These latter are defined as patients who have relapsed after having experienced stable disease (lasting at least six months) or partial response with prior treatment with an approved antiangiogenic regimen or patients with tumour types known to be potentially responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic agents were approved and/or available for that specific condition (e.g thyroid cancer, thymic carcinoma).  Serial safety assessments, including evaluation of symptoms, physical examination and blood and urine laboratory analyses are performed throughout the study. Cardiac functions and blood pressure are monitored in consultation with a cardiologist. PK parameters are determined on plasma samples collected during the first 4-week cycle and analyzed using a validated LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of angiogenesis biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and PIGF(by ELISA) and circulating endothelial and progenitors cells (CEC and CEP). Tumor response is based on imaging according to RECIST; circulating tumor cells (CTC) are measured by the immunomagnetic CellSearch method.  In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30, power 0,80. 
Sponsor: Institut de Recherches Internationales Servier 
Intervention: Lucitanib 
Start Date: 2010-07 
Last Updated: 2020-01-03 
Number of Patients: 134 
Recruitment Status: COMPLETED 
Condition: Solid Tumors 

NCTID: NCT00003215

Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin’s lymphoma.  PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin’s lymphoma. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: filgrastim 
Start Date: 1997-04 
Last Updated: 2012-05-15 
Number of Patients: 400 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT04459715

Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) 
Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Xevinapant (Debio 1143) 
Start Date: 2020-08-07 
Last Updated: 2023-10-24 
Number of Patients: 730 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Squamous Cell Carcinoma of the Head and Neck 

NCTID: NCT03965468

Title: Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC 
Study Summary: A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy plus stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the locoregional primary tumour, in patients with histologically-confirmed synchronous oligo-metastatic non-small cell lung cancer (NSCLC). 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Durvalumab 
Start Date: 2019-11-19 
Last Updated: 2023-09-28 
Number of Patients: 96 
Recruitment Status: RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT00006249

Title: Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma 
Study Summary: RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.  PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: pegylated interferon alfa 
Start Date: 2000-06 
Last Updated: 2015-02-10 
Number of Patients: 1258 
Recruitment Status: UNKNOWN 
Condition: Melanoma (Skin) 

NCTID: NCT04304352

Title: Metronomic Oral Chemotherapy With Cyclophosphamide, Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients 
Study Summary: This is a phase II study assessing the activity and safety of metronomic chemotherapy with cyclophosphamide and capecitabine and vinorelbine in advanced breast cancer patient in four different cohort of patients:  # Untreated (naïve) patients with endocrine responsive disease # Pretreated patients with endocrine responsive disease # Untreated (naïve) patients with triple negative disease # Pretreated patients with triple negative disease The primary endpoint will be the progression-free survival 
Sponsor: European Institute of Oncology 
Intervention: Vinorelbine 
Start Date: 2011-07-29 
Last Updated: 2023-06-28 
Number of Patients: 162 
Recruitment Status: RECRUITING 
Condition: Advanced Breast Cancer 

NCTID: NCT04049305

Title: Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer 
Study Summary: This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the management of breast cancer. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM. 
Sponsor: Changhua Christian Hospital 
Intervention: Robotic assisted nipple sparing mastectomy (R-NSM) 
Start Date: 2019-08-22 
Last Updated: 2020-07-16 
Number of Patients: 900 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer Female 

NCTID: NCT00054626

Title: Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer.  PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder. 
Sponsor: Fondazione C.N.R./Regione Toscana “G. Monasterio”, Pisa, Italy 
Intervention: cisplatin 
Start Date: 2001-09 
Last Updated: 2013-12-18 
Number of Patients: 700 
Recruitment Status: UNKNOWN 
Condition: Bladder Cancer 

NCTID: NCT00005052

Title: Vaccine Therapy in Treating Patients With Primary Stage II Melanoma 
Study Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.  PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: GM2-KLH vaccine 
Start Date: 1999-12 
Last Updated: 2009-02-09 
Number of Patients: NA 
Recruitment Status: UNKNOWN 
Condition: Melanoma (Skin) 

NCTID: NCT03390504

Title: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations 
Study Summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-<math display="block">L</math>1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Erdafitinib 
Start Date: 2018-03-23 
Last Updated: 2023-11-13 
Number of Patients: 629 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urothelial Cancer 

NCTID: NCT01540552

Title: Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer 
Study Summary: RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment.  PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer. 
Sponsor: M.D. Anderson Cancer Center 
Intervention: medical chart review 
Start Date: 2012-02 
Last Updated: 2013-01-25 
Number of Patients: 320 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT04919226

Title: Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE 
Study Summary: The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. 
Sponsor: ITM Solucin GmbH 
Intervention: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT 
Start Date: 2021-12-21 
Last Updated: 2023-09-13 
Number of Patients: 202 
Recruitment Status: RECRUITING 
Condition: Neuroendocrine Tumors 

NCTID: NCT01913717

Title: Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion 
Study Summary: The present research project aims to improve the current treatment for prostate-confined tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy schedule administered with one of the best available dose delivery systems. The study will include 2 sub-studies (in-silica and clinical study) and 4 tasks. 
Sponsor: European Institute of Oncology 
Intervention: External beam radiotherapy 
Start Date: 2014-01 
Last Updated: 2023-06-28 
Number of Patients: 65 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Adenocarcinoma of Prostate 

NCTID: NCT03650517

Title: Minimally Invasive Right Colectomy Anastomosis Study 
Study Summary: Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.  A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.  However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.  MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:  # Robotic Right Colectomy with ICA # Robotic Right Colectomy with ECA # Laparoscopic Right Colectomy with ICA # Laparoscopic Right Colectomy with ECA  All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery. 
Sponsor: Instituto de Investigación Marqués de Valdecilla 
Intervention: Extracorporeal Anastomosis 
Start Date: 2018-11-01 
Last Updated: 2019-09-25 
Number of Patients: 1200 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer 

NCTID: NCT00911027

Title: SonoVue Guided Prostate Biopsy 
Study Summary: This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers. 
Sponsor: Bracco Diagnostics, Inc 
Intervention: Contrast-enhanced ultrasound guided biopsy 
Start Date: 2009-02 
Last Updated: 2012-04-25 
Number of Patients: 282 
Recruitment Status: TERMINATED 
Condition: Prostate Cancer 

NCTID: NCT05125991

Title: Evaluation of the Effectiveness of Prepectoral Breast Reconstruction 
Study Summary: The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated. 
Sponsor: European Institute of Oncology 
Intervention: Prepectoral reconstruction 
Start Date: 2019-09-03 
Last Updated: 2023-08-24 
Number of Patients: 58 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04463771

Title: Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. 
Study Summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents. 
Sponsor: Incyte Corporation 
Intervention: retifanlimab 
Start Date: 2021-01-26 
Last Updated: 2023-10-26 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Endometrial Cancer 

NCTID: NCT02273375

Title: Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC 
Study Summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer. 
Sponsor: Canadian Cancer Trials Group 
Intervention: MEDI4736 
Start Date: 2015-02-24 
Last Updated: 2023-10-27 
Number of Patients: 1415 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT04828850

Title: Preoperative Lymph Node Staging With EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer 
Study Summary: The introduction of modern staging systems has increased the detection of small peripheral lung cancers at an early stage <math display="block">1</math>. Stage I non-small-cell lung cancers (NSCLCs) are confined to the lung without lymph node involvement, and surgical resection is currently considered the standard therapeutic approach.  Nodal staging is initially performed non-invasively with computer tomography (CT) and positron emission tomography (PET) scans followed by minimally invasive staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) when CT and/or PET are suggestive of mediastinal nodal involvement. Lobectomy with radical lymphadenectomy is currently considered the treatment of choice for early-stage lung cancer.  Several studies demonstrated that primary invasive non- small-cell lung carcinomas > 2.0 cm were twice as likely to have nodal metastases as carcinomas ≤ 2.0 cm, emphasizing that small lung cancers had less lymph node involvement and confirming a better survival. In our pilot study <math display="block">18</math> published in 2011 in the European Journal of Thoracic Surgery, no nodal involvement was observed in any of the 62 patients with pulmonary nodule size less than 10 mm, in 20 out of 120 patients (17%) with nodule size 11-20 mm, and in 9 out of 37 tumors (24%) 21-30 mm in size (p = 0.0007).  These patients could be spared radical lymph node dissection if deemed not essential, thereby reducing operative risks, postoperative morbidity, and surgery time. A preoperative diagnostic determination to establish the size and correct staging of the tumor is mandatory for appropriate selection of candidates, avoiding unnecessary surgery. 
Sponsor: European Institute of Oncology 
Intervention: Endobronchial ultrasound transbronchial needle aspiration lymph node staging 
Start Date: 2021-04-01 
Last Updated: 2022-03-22 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT03673306

Title: Safety of Pregnancy in BRCA Mutated Breast Cancer Patients 
Study Summary: The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer. 
Sponsor: Jules Bordet Institute 
Intervention: Clinical outcomes 
Start Date: 2017-01-16 
Last Updated: 2018-09-17 
Number of Patients: 2200 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer 

NCTID: NCT01134250

Title: Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients 
Study Summary: This Phase Ib/II study is an open label, multicenter study.  The study is divided in two parts:  Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma, mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy.  Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design, for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy. 
Sponsor: Philogen S.p.A. 
Intervention: F16IL2 in combination with paclitaxel 
Start Date: 2008-08-06 
Last Updated: 2022-04-15 
Number of Patients: 48 
Recruitment Status: COMPLETED 
Condition: Solid Tumor 

NCTID: NCT03712696

Title: Efficacy and Safety of DIGNICAP™ System 
Study Summary: Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy.  In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT).  A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years.  The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose. 
Sponsor: European Institute of Oncology 
Intervention: DIGNICAP™ 
Start Date: 2014-07-18 
Last Updated: 2018-10-19 
Number of Patients: 139 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00295100

Title: Tamoxifen-MRI Study 
Study Summary: The project is a double blind, randomized, placebo-controlled phase II chemoprevention trial. Study participants will be randomly assigned to receive either tamoxifen or placebo for one year. Participants will subsequently be followed for one year off of medication. The primary objective is to evaluate the effectiveness of tamoxifen in reducing breast density by mammogram. 
Sponsor: University of Pennsylvania 
Intervention: Tamoxifen 
Start Date: 2000-09 
Last Updated: 2007-06-21 
Number of Patients: 78 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01479192

Title: Fenretinide in Healthy Young Women at Genetic and Familial Risk 
Study Summary: The purpose of this trial is to assess the effect of fenretinide (4-HPR), a vitamin A derivative, in reducing the incidence of breast cancer in healthy premenopausal women at increased familial/genetic risk for breast cancer 
Sponsor: European Institute of Oncology 
Intervention: Fenretinide 
Start Date: 2009-12 
Last Updated: 2018-11-07 
Number of Patients: 20 
Recruitment Status: TERMINATED 
Condition: High-Risk Cancer 

NCTID: NCT02709512

Title: Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin 
Study Summary: This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die. 
Sponsor: Polaris Group 
Intervention: ADI-PEG 20 plus Pem Platinum 
Start Date: 2017-08-01 
Last Updated: 2023-10-04 
Number of Patients: 249 
Recruitment Status: COMPLETED 
Condition: Mesothelioma 

NCTID: NCT05410951

Title: LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients 
Study Summary: This is a cross-sectional and retrospective study of a cohort of patients with invasive lobular breast cancer (LBC) or in situ lobular neoplasia (LIN3).  The main endpoint is the relative frequency of patients with a germline mutation using a recent panel including 113 genes from the “Illumina” protocol.  In case of identification of a novel pathogenetic germline mutations, a personalized follow-up will be offered to each patient (in case of genes at moderate-, low-penetrance), or prophylactic mastectomy (in case of genes at high-penetrance).  Breast screening in moderate-, low-penetrance mutated patients should be performed periodically using digital mammography, ultrasound and MRI, and will be routinely observed.  Patients will be scheduled for follow-up at six-month intervals for 5 years at our outpatient clinic, and yearly thereafter 
Sponsor: European Institute of Oncology 
Intervention: Illumina panel 
Start Date: 2022-05-16 
Last Updated: 2023-09-21 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: Lobular Breast Carcinoma 

NCTID: NCT02422914

Title: Benefits of Tobacco Free Cigarette 
Study Summary: Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic.  Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual’s risk.  Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC.  The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited.  All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities. 
Sponsor: University of Milan 
Intervention: Smoking cessation program TFC and activity tracker 
Start Date: 2014-09 
Last Updated: 2015-04-22 
Number of Patients: 210 
Recruitment Status: UNKNOWN 
Condition: Cigarette Smoking 

NCTID: NCT00940030

Title: Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma 
Study Summary: The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal resection for malignancy. 
Sponsor: European Institute of Oncology 
Intervention: mechanical bowel preparation 
Start Date: 2007-10 
Last Updated: 2018-11-07 
Number of Patients: 440 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT00516412

Title: Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma 
Study Summary: RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.  PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: everolimus 
Start Date: 2007-08 
Last Updated: 2015-09-29 
Number of Patients: 35 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT02637765

Title: Life ImproVed by Exercise (LIVE Trial) 
Study Summary: This is a prospective randomized controlled trial in which patients with previous breast cancer will be randomized into two treatment arms:  # Control Group of Usual Physical Activity # Intervention Group of Increased Physical Activity  No specific intervention will be performed In the patients randomized in the control group.  Patients randomized in the Intervention group will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time patients of this group will receive an 8-week recreational program of brisk walking/running (3 times a week).  All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able to count the number of steps, determine a daily goal of steps, determine the covered distance (in Km), determine daily caloric consumption, and determine the movements during sleep. 
Sponsor: European Institute of Oncology 
Intervention: Increased Physical Activity 
Start Date: 2014-07 
Last Updated: 2021-09-16 
Number of Patients: 206 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT06139588

Title: Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction 
Study Summary: The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss)  The main questions the study aims to answer are:  * is one of the two matrices better than the other? (better results with fewer complications) * is there a group of patients who benefit more than another from the use of this type of devices? * is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices.  Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications. 
Sponsor: European Institute of Oncology 
Intervention: acellular dermal matrix implant for breast reconstruction 
Start Date: 2017-06-01 
Last Updated: 2023-11-18 
Number of Patients: 146 
Recruitment Status: COMPLETED 
Condition: Breast Implant; Complications 

NCTID: NCT00062400

Title: Assessing Women’s Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer 
Study Summary: RATIONALE: Adjuvant therapy given after surgery for early breast cancer may cause infertility. Assessing young women’s attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment.  PURPOSE: This clinical trial is studying young women’s attitudes and feelings about the risk of infertility related to adjuvant therapy for stage I or stage II breast cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: psychosocial assessment and care 
Start Date: 2003-05 
Last Updated: 2013-10-24 
Number of Patients: 385 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04209855

Title: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression 
Study Summary: This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. 
Sponsor: ImmunoGen, Inc. 
Intervention: Mirvetuximab Soravtansine 
Start Date: 2019-12-31 
Last Updated: 2023-03-06 
Number of Patients: 453 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Epithelial Ovarian Cancer 

NCTID: NCT01763125

Title: Establishment of a Tumor Bank for Blood Samples 
Study Summary: Establishment of a tumor bank, consisting of blood samples of tumor patients and healthy people as controls. The blood samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tumor bank. 
Sponsor: Medical University of Vienna 
Intervention: Blood collection 
Start Date: 2003-11 
Last Updated: 2023-03-23 
Number of Patients: 10000 
Recruitment Status: RECRUITING 
Condition: Ovarian Neoplasms 

NCTID: NCT00296010

Title: Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer.  PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: cyclophosphamide 
Start Date: 2005-08 
Last Updated: 2021-02-23 
Number of Patients: 77 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT01500577

Title: A Prevention Trial in Subjects at High Risk for Breast Cancer 
Study Summary: The primary objective of the proposed trial is to assess. The efficacy and the safety of a daily administration of nimesulide or simvastatin to change the expression of a large set of tissue and circulating surrogate endpoint biomarkers (SEBs) of breast carcinogenesis in women at higher risk of developing a hormone non-responsive (ER neg) breast cancer. The primary endpoint is the change in prevalence of atypical cells and cellular proliferation (Ki-67), after 12 months of treatment. 
Sponsor: European Institute of Oncology 
Intervention: nimesulide 
Start Date: 2005-04 
Last Updated: 2014-06-18 
Number of Patients: 150 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00659867

Title: Endomicroscopy in Ulcerative Colitis 
Study Summary: This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy. 
Sponsor: PENTAX Europe GmbH 
Intervention: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes 
Start Date: 2008-12 
Last Updated: 2016-09-27 
Number of Patients: 182 
Recruitment Status: TERMINATED 
Condition: Ulcerative Colitis 

NCTID: NCT04472429

Title: Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). 
Study Summary: This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy. 
Sponsor: Incyte Corporation 
Intervention: carboplatin 
Start Date: 2021-01-12 
Last Updated: 2023-07-12 
Number of Patients: 308 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Squamous Cell Carcinoma of the Anal Canal 

NCTID: NCT04086264

Title: IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia 
Study Summary: This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML. 
Sponsor: ImmunoGen, Inc. 
Intervention: Azacitidine 
Start Date: 2019-11-06 
Last Updated: 2023-10-06 
Number of Patients: 292 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT00005060

Title: Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.  PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: Taxotere-Cisplatin-5FU 
Start Date: 1999-11 
Last Updated: 2012-05-15 
Number of Patients: 240 
Recruitment Status: COMPLETED 
Condition: Gastric Cancer 

NCTID: NCT05208229

Title: The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA) 
Study Summary: The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA 
Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori 
Intervention: WB-MRI 
Start Date: 2022-10-25 
Last Updated: 2023-06-01 
Number of Patients: 40 
Recruitment Status: TERMINATED 
Condition: Metastatic Castration Resistant Prostate Cancer (mCRPC) 

NCTID: NCT00742677

Title: Feeding Schedules After Surgery in Patients With Gynecologic Cancer 
Study Summary: RATIONALE: Abdominal pain and nausea and vomiting may be lessened by waiting after surgery before eating foods by mouth. It is not yet known which feeding schedule is more effective in patients undergoing surgery.  PURPOSE: This randomized clinical trial is comparing two feeding schedules after laparotomy in patients with gynecologic cancer. 
Sponsor: European Institute of Oncology 
Intervention: nutritional support 
Start Date: 2007-01 
Last Updated: 2013-09-20 
Number of Patients: 180 
Recruitment Status: UNKNOWN 
Condition: Female Reproductive Cancer 

NCTID: NCT01671462

Title: European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System 
Study Summary: The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy. 
Sponsor: Becton, Dickinson and Company 
Intervention: BD HPV assay on Viper LT 
Start Date: 2012-08 
Last Updated: 2014-02-20 
Number of Patients: 1365 
Recruitment Status: COMPLETED 
Condition: Uterine Cervical Neoplasms 

NCTID: NCT00045032

Title: Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer 
Study Summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation 

o Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Sponsor: Hoffmann-La Roche 
Intervention: Herceptin 
Start Date: 2001-11 
Last Updated: 2017-04-27 
Number of Patients: 5099 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00553410

Title: Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer 
Study Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.  PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Letrozole 
Start Date: 2007-08 
Last Updated: 2020-03-11 
Number of Patients: 4884 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00110123

Title: Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different ways may kill more tumor cells. It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases.  PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: fotemustine 
Start Date: 2005-01 
Last Updated: 2012-09-24 
Number of Patients: 171 
Recruitment Status: TERMINATED 
Condition: Intraocular Melanoma 

NCTID: NCT01357772

Title: Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up 
Study Summary: The aim of the study is to evaluate whether tamoxifen at a low dose of 5mg/d reduces in the long term the incidence of invasive breast cancer and ductal carcinoma in situ, DCIS (DIN 1c, 2, 3) of the breast, in woman operated for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN 1b, DIN2, DIN3, 1a excluded) of the breast.  To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.  Biomarker trials revealed that 5 mg/d was noninferior to 20 mg/d in inhibiting proliferation of breast cancer and normal endometrial tissue.  By contrast, the risk of endometrial cancer si dose-dependent, and the dose reduction can lead a substantial decrease. Morover a dose of 5 mg/day is associated with an overall decrease of the estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding globulin (SHBG) and antithrombin-III, with a decrease of venous thromboembolic events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day attains at the breast tissue level a concentration 10 times higher than that needed to inhibit cell growth in vitro.  A prospective cohort study also showed that 10 mg on alternate days halves recurrence of DCIS in postmenopausal women.  It has been shown that the treatment of dysplasia or pre-cancer drives the reduction of the invasive neoplasms onset. This is a chemoprevention trial designed to validatate the low-dose Tamoxifen in women with diseases at high evolutionary risk. The demonstration of efficacy and safety of such a treatment for the prevention of the invasive breast cancer would lead improvements in term of survival and quality of life for the patients at increased risk. 
Sponsor: Andrea DeCensi 
Intervention: Tamoxifen 
Start Date: 2008-11-12 
Last Updated: 2023-07-17 
Number of Patients: 500 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Intraductal, Noninfiltrating 

NCTID: NCT01654692

Title: A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma 
Study Summary: This study is designed to assess the safety and efficacy of a combination of ipilimumab and fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma. 
Sponsor: Italian Network for Tumor Biotherapy 
Intervention: Ipilimumab and Fotemustine 
Start Date: 2010-06 
Last Updated: 2015-05-13 
Number of Patients: 86 
Recruitment Status: COMPLETED 
Condition: Metastatic Malignant Melanoma 

NCTID: NCT01808573

Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting 
Study Summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. 
Sponsor: Puma Biotechnology, Inc. 
Intervention: neratinib 
Start Date: 2013-03-29 
Last Updated: 2021-06-11 
Number of Patients: 621 
Recruitment Status: COMPLETED 
Condition: HER2+ Metastatic Breast Cancer (MBC) 

NCTID: NCT02305810

Title: A Biological Prospective Study in Patients With Metastatic Pancreatic NETs Treated With Everolimus 
Study Summary: Everolimus represents an approved therapy for patients with advanced well/moderately differentiated pancreatic NETs. Although some patients could benefit from this drug in terms of long-term tumor growth control, others are resistant upfront or become resistant during treatment. Therefore, it is crucial to detect some biological factors which can help to identify the responsive tumors. Given that Everolimus is a biological agent and its mechanism of action can be partially directed towards angiogenesis its effects can be studied on different levels and with different methods. Upfront and early surrogate predictive markers of activity/efficacy can be studied on tumor tissue, tumor imaging, and peripheral blood. mTOR pathways alterations, circulating endothelial cells, and other circulating angoigenic factors will be correlated with clinical outcome. Tumor perfusion and circulating markers will be studied also as markers of response compared with the morphological imaging. 
Sponsor: European Institute of Oncology 
Intervention: Everolimus 10 mg daily 
Start Date: 2013-09 
Last Updated: 2018-11-07 
Number of Patients: 54 
Recruitment Status: COMPLETED 
Condition: Pancreatic Neuroendocrine Tumour Metastatic 

NCTID: NCT02694562

Title: Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy 
Study Summary: The purpose of this study is to determine safety and local tumor control of Embozene TANDEM Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma (mCRC). 
Sponsor: Boston Scientific Corporation 
Intervention: 40um Embozene TANDEM Microspheres 
Start Date: 2013-11 
Last Updated: 2019-02-15 
Number of Patients: 18 
Recruitment Status: COMPLETED 
Condition: Colorectal Carcinoma 

NCTID: NCT00981110

Title: Standard Versus Advanced Antimicrobial Dressing Containing Ionic Silver Following Colorectal Cancer Surgery 
Study Summary: The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site infections (SSI) in patients who underwent colorectal resection for malignancy. 
Sponsor: European Institute of Oncology 
Intervention: AQUAGEL Ag Hydrofiber Wound Dressing 
Start Date: 2008-06 
Last Updated: 2012-09-11 
Number of Patients: 120 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT05932758

Title: Excisional Vacuum-Assisted Breast Biopsy 
Study Summary: The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS). 
Sponsor: European Institute of Oncology 
Intervention: Vacuum-assisted excisional biopsy 
Start Date: 2023-01-17 
Last Updated: 2023-07-21 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Atypical Ductal Hyperplasia 

NCTID: NCT02356458

Title: Combination of Ibrutinib and Bortezomib to Treat Patients With Mantle Cell Lymphoma 
Study Summary: Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no standard therapeutic options in case of relapse. Prolongation of remissions or induction of longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown. These findings, along with the reported single agent activities of both drugs and the non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in this trial 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: Ibrutinib 
Start Date: 2015-08-31 
Last Updated: 2022-03-11 
Number of Patients: 58 
Recruitment Status: TERMINATED 
Condition: Mantle Cell Lymphoma 

NCTID: NCT04398524

Title: A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC 
Study Summary: This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. 
Sponsor: ISA Pharmaceuticals 
Intervention: ISA101b 
Start Date: 2021-07-01 
Last Updated: 2023-04-12 
Number of Patients: 86 
Recruitment Status: RECRUITING 
Condition: Squamous Cell Carcinoma of the Oropharynx 

NCTID: NCT02828618

Title: Trial on Radical Upfront Surgery in Advanced Ovarian Cancer 
Study Summary: This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.  All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.  TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other. 
Sponsor: AGO Study Group 
Intervention: PDS (Primary Debulkdung Surgery) 
Start Date: 2016-07 
Last Updated: 2023-02-03 
Number of Patients: 797 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT00072462

Title: Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.  PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ. 
Sponsor: Queen Mary University of London 
Intervention: tamoxifen citrate 
Start Date: 2003-09 
Last Updated: 2021-10-06 
Number of Patients: 2980 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01375023

Title: Allogenic Haematopoietic Cell Transplantation for Patients With Refractory “Triple Negative” Breast Cancer 
Study Summary: The purpose of this study is to evaluate the engraftment, toxicity and anti-tumour activity of allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning regimen in patients with refractory “Triple Negative” breast cancer. 
Sponsor: European Institute of Oncology 
Intervention: Radiotherapy 
Start Date: 2009-06 
Last Updated: 2015-06-22 
Number of Patients: 3 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT02264418

Title: Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours 
Study Summary: The purpose of this first-in-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities. 
Sponsor: Orion Corporation, Orion Pharma 
Intervention: ODM 203 
Start Date: 2014-09-18 
Last Updated: 2020-01-18 
Number of Patients: 84 
Recruitment Status: COMPLETED 
Condition: Solid Tumours 

NCTID: NCT05155618

Title: Intervention Study in Prostate Cancer Patients Undergoing Radiotherapy 
Study Summary: Microstyle study aims to evaluate the effect of a 6-month intervention in a group of prostate cancer patients undergoing radiotherapy. Intervention is designed to control side effects and to improve adherence to a healthy lifestyle (diet and increase level of physical activity and decreased sedentary time) measured by the change in adherence to a healthy lifestyle score. The impact of the intervention on toxicity and gastrointestinal symptomatology will be measured by a mediation framework analysis. This approach allows investigating how microbiome may mediate effect of treatment. It will be also assessed the change in microbiome in relation to the change in cytokines/ adipokines in association with early and late toxicity. 
Sponsor: European Institute of Oncology 
Intervention: INTERVENTION GROUP 
Start Date: 2021-11-08 
Last Updated: 2023-06-28 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT05963464

Title: SCOUT® Radar Localization in Nonpalpable Breast Lesions 
Study Summary: This is a monocentric prospective observational study for patients with clinical undetectable breast lesions and indications to breast conserving surgery for histological characterization.  The SCOUT® Radar occult breast lesion Localization (SRL) consists of an implantable reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to guide surgical excision in real time.  The study describes the experience with 300 patients at the European Institute of Oncology.  The primary endpoints of the study are the rates of successful positioning, localization and recovery of the reflector SRL. 
Sponsor: European Institute of Oncology 
Intervention: SCOUT® Radar occult breast lesion Localization 
Start Date: 2023-02-01 
Last Updated: 2023-08-01 
Number of Patients: 300 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01131364

Title: Combination Therapy of F16IL2 and Doxorubicin in Solid Tumour Patients 
Study Summary: This Phase Ib/II study is an openlabel, multicenter study for patients with solid tumors and breast cancer amenable to anthracyclin therapy.  The study is divided in two parts:  Phase I: an open-label, dose escalation study of F16IL2 in combination with doxorubicin for patients with solid tumors.  Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with doxorubicin, equivalent to stage 1 of the Simon two-stage phase II design, for patients with breast cancer amenable to anthracyclin therapy. 
Sponsor: Philogen S.p.A. 
Intervention: F16IL2 in combination with doxorubicin 
Start Date: 2008-06 
Last Updated: 2014-02-25 
Number of Patients: 29 
Recruitment Status: TERMINATED 
Condition: Advanced Solid Tumor 

NCTID: NCT03440398

Title: Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique 
Study Summary: This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction 
Sponsor: European Institute of Oncology 
Intervention: Robotic NSM 
Start Date: 2017-03-31 
Last Updated: 2023-06-28 
Number of Patients: 82 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04497844

Title: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) 
Study Summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Niraparib 
Start Date: 2020-09-23 
Last Updated: 2023-11-09 
Number of Patients: 696 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Castration-sensitive Prostate Cancer 

NCTID: NCT03656536

Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement. 
Sponsor: Incyte Corporation 
Intervention: Pemigatinib 
Start Date: 2019-06-03 
Last Updated: 2023-11-15 
Number of Patients: 434 
Recruitment Status: RECRUITING 
Condition: Unresectable Cholangiocarcinoma 

NCTID: NCT04227444

Title: Preoperative Evaluation of Pulmonary Vascular Anatomy by Holograms 
Study Summary: Pulmonary vascular anatomy represents a constant challenge during lung resection, because of its variability in terms of vascular branches and anatomical variations.  Preoperative standard computed tomography is not always sufficient to foresee tricky abnormalities; augmented reality, thanks to holograms creation, may offer additional data on pulmonary vascular anatomy and its relation with neoplastic tissue. The aim of this study is to assess the possibility of correctly predict number, location and potential anomalies of pulmonary vascular anatomy of the lobe to be resected in patients undergoing lung resection for cancer.  Patients will receive standard preoperative oncologic and functional assessment. Preoperative computed tomography (CT) - performed according to a specific protocol - will be performed. CT images will be subsequently elaborated to generate 3D images (holograms). Two radiologists and two thoracic surgeons will analyze CT images and report number of artery and vein branches for the lobe to be resected. Moreover they will report every anatomical variation, according to the normal anatomy. After that, the same two radiologists and thoracic surgeons will analyze the holograms and perform the same analysis as quoted above. Patients will undergo to the planned surgical resection. The operating team will report the exact number of artery and vein branches of the resected lobe as well as every anatomical variation. Preoperative CT and holographic findings of the radiologists and the thoracic surgeons will be matched with the report of the operating team. 
Sponsor: European Institute of Oncology 
Intervention: Hologram 
Start Date: 2020-03-01 
Last Updated: 2023-06-28 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Pulmonary Disease 

NCTID: NCT00004935

Title: Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2 
Study Summary: RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer.  PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: Herceptin™ (Her) 
Start Date: 1999-08-30 
Last Updated: 2023-04-18 
Number of Patients: 175 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT05287113

Title: Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck 
Study Summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). 
Sponsor: Incyte Biosciences International Sàrl 
Intervention: Retifanlimab 
Start Date: 2022-11-14 
Last Updated: 2023-11-09 
Number of Patients: 162 
Recruitment Status: RECRUITING 
Condition: Head and Neck Cancer 

NCTID: NCT05388669

Title: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer 
Study Summary: The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Lazertinib 
Start Date: 2022-08-05 
Last Updated: 2023-11-08 
Number of Patients: 418 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced or Metastatic Non-small Cell Lung Cancer 

NCTID: NCT01264874

Title: MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients 
Study Summary: The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients. 
Sponsor: European Institute of Oncology 
Intervention: Vitamin D3 ( Colecalciferol) 
Start Date: 2010-05 
Last Updated: 2018-01-31 
Number of Patients: 150 
Recruitment Status: TERMINATED 
Condition: Melanoma 

NCTID: NCT02664974

Title: Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer 
Study Summary: Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.  The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group). 
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 
Intervention: Enteral nutrition 
Start Date: 2008-12 
Last Updated: 2016-01-27 
Number of Patients: 79 
Recruitment Status: COMPLETED 
Condition: Malnutrition 

NCTID: NCT03599713

Title: A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201) 
Study Summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC). 
Sponsor: Incyte Corporation 
Intervention: Retifanlimab 
Start Date: 2019-02-25 
Last Updated: 2023-10-26 
Number of Patients: 107 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Merkel Cell Carcinoma 

NCTID: NCT00614211

Title: Laparoscopic Approach to Cervical Cancer 
Study Summary: The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology. 
Sponsor: Queensland Centre for Gynaecological Cancer 
Intervention: Total Abdominal Radical Hysterectomy 
Start Date: 2008-01 
Last Updated: 2023-04-18 
Number of Patients: 636 
Recruitment Status: COMPLETED 
Condition: Cervical Cancer 

NCTID: NCT04871399

Title: Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer 
Study Summary: An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy. 
Sponsor: University of Turin, Italy 
Intervention: Conventional Right hemicolectomy (Non-CME) 
Start Date: 2020-07-13 
Last Updated: 2022-11-14 
Number of Patients: 416 
Recruitment Status: RECRUITING 
Condition: Colon Cancer 

NCTID: NCT01579734

Title: Phase III, Randomized, Double Blind Trial Low Dose Tamoxifen Versus Placebo in Hormone Replacement Therapy (HRT) Users 
Study Summary: The propose of this trial is to assess the effect of low dose tamoxifen for breast cancer prevention in HRT (Hormone Replacement Therapy)users. 
Sponsor: European Institute of Oncology 
Intervention: Tamoxifen 
Start Date: 2002-03 
Last Updated: 2023-06-28 
Number of Patients: 1884 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00068601

Title: S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer 
Study Summary: RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.  PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer. 
Sponsor: SWOG Cancer Research Network 
Intervention: cyclophosphamide 
Start Date: 2003-10 
Last Updated: 2019-12-30 
Number of Patients: 257 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02933801

Title: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents. 
Study Summary: The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: ODM-201 
Start Date: 2017-03-31 
Last Updated: 2023-03-08 
Number of Patients: 92 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer Metastatic 

NCTID: NCT02598557

Title: Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer 
Study Summary: This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol. 
Sponsor: National Cancer Institute (NCI) 
Intervention: Exemestane 
Start Date: 2016-12-06 
Last Updated: 2023-08-22 
Number of Patients: 180 
Recruitment Status: COMPLETED 
Condition: Stage 0 Breast Cancer AJCC v6 and v7 

NCTID: NCT00945724

Title: Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis 
Study Summary: This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy. 
Sponsor: International Extranodal Lymphoma Study Group (IELSG) 
Intervention: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate 
Start Date: 2009-04 
Last Updated: 2023-03-10 
Number of Patients: 54 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Large B-cell Diffuse Lymphoma of Testis 

NCTID: NCT01374841

Title: Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors 
Study Summary: The purpose of this study is to determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative transplant with peripheral stem cells from Human Leukocyte Antigen (HLA) haploidentical donors with pre and post-transplant cyclophosphamide as immunosuppression. 
Sponsor: European Institute of Oncology 
Intervention: Cyclophosphamide 
Start Date: 2010-08 
Last Updated: 2023-06-28 
Number of Patients: 20 
Recruitment Status: RECRUITING 
Condition: Hematologic Neoplasms 

NCTID: NCT03001570

Title: Accelerated Modulated Fractionation (SIB-IMRT) for Head and Neck District 
Study Summary: Nowadays the association between radiotherapy and the anti- Epidermal Growth Factor Receptor (anti-EGFR) monoclonal antibody Cetuximab represents a valid option in the treatment of head and neck locally advanced squamous neoplasm and, particularly, of oropharynx carcinoma. Up to date we have only indirect comparison with the standard curative treatment (i.e. concurrent radiochemotherapy) and the preliminary data show equivalent efficacy of both regimens. For this reason, concurrent Cetuximab and radiotherapy is administered in patients not eligible to chemoradiotherapy. The introduction of Cetuximab has been associated to new kind of toxicities, especially cutaneous, that have increasingly reported.  The aim of our study is to improve the toxicity/benefit ratio in patients receiving concurrent radiotherapy and cetuximab for locally advanced head and neck neoplasm. Hence, this improvement could be achieved by modulating radiation therapy dose per fraction following Cetuximab pharmacokinetics. 
Sponsor: European Institute of Oncology 
Intervention: Cetuximab plus Radiotherapy 
Start Date: 2014-01 
Last Updated: 2023-06-28 
Number of Patients: 10 
Recruitment Status: RECRUITING 
Condition: Carcinoma of the Head and Neck 

NCTID: NCT00014599

Title: Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.  PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: paclitaxel 
Start Date: 2001-02 
Last Updated: 2012-09-24 
Number of Patients: 31 
Recruitment Status: COMPLETED 
Condition: Vulvar Cancer

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial