Trials (Institute of Oncology Ljubljana)

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NCTID: NCT06060990

Title: Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers 
Study Summary: The aim of the study is to determine the total concentration of selected trace elements (Cu, Zn, Fe), the proportion of free Cu and Cu bound to ceruloplasmin and the isotopic ratio of Cu65/Cu63 in blood serum samples from healthy volunteers and cancer patients using inductively coupled plasma mass spectrometry-based methods. The results will be statistically evaluated and the potential applications of the analytical methods used in cancer diagnosis and therapy will be assessed. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: trace elements 
Start Date: 2023-01-01 
Last Updated: 2023-09-29 
Number of Patients: 20 
Recruitment Status: RECRUITING 
Condition: Trace Element Deficiency 

NCTID: NCT05916690

Title: Electrochemotherapy for the Treatment of Vulvar Cancer 
Study Summary: Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Electrochemotherapy with bleomycin or cisplatin 
Start Date: 2021-03-01 
Last Updated: 2023-06-23 
Number of Patients: 20 
Recruitment Status: RECRUITING 
Condition: Vulvar Cancer 

NCTID: NCT02352259

Title: Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II 
Study Summary: The study is prospective, phase II study, The primary objective of the study is evaluation of the feasibility and safety of intraoperative electrochemotherapy of colorectal liver metastases. The secondary objective is to determine the efficacy of electrochemotherapy treatment, based on histological and radiological evaluation of treated metastases. The endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST criteria. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Electrochemotherapy 
Start Date: 2013-09 
Last Updated: 2021-03-24 
Number of Patients: 23 
Recruitment Status: COMPLETED 
Condition: Liver Metastases 

NCTID: NCT02302807

Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] 
Study Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody 
Start Date: 2015-01-13 
Last Updated: 2019-08-01 
Number of Patients: 931 
Recruitment Status: COMPLETED 
Condition: Bladder Cancer 

NCTID: NCT05077033

Title: Intratumoral phIL12 GET 
Study Summary: Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid coding for IL-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. The EU directives recommend the use of plasmids without the gene for antibiotic resistance. For this purpose we constructed plasmid coding for IL-12 in accordance with the EU regulatory requirements.  In the proposed study we intend to study the safety and tolerability of the constructed plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. The study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces IL-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: phIL12 GET 
Start Date: 2021-09-28 
Last Updated: 2022-11-14 
Number of Patients: 9 
Recruitment Status: RECRUITING 
Condition: Basal Cell Carcinoma 

NCTID: NCT00004179

Title: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin’s lymphoma.  PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin’s lymphoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: rituximab 
Start Date: 1999-05 
Last Updated: 2021-02-15 
Number of Patients: 475 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT01281800

Title: Cisplatin With Alimta or Gemcitabine in Long Infusion for Mesothelioma 
Study Summary: This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Gemcitabine in long infusion 
Start Date: 2008-08 
Last Updated: 2011-01-24 
Number of Patients: 72 
Recruitment Status: UNKNOWN 
Condition: Mesothelioma 

NCTID: NCT00002539

Title: Combination Chemotherapy and Surgery With or Without G-CSF in Treating Patients With Osteosarcoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person’s immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma.  PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: filgrastim 
Start Date: 1993-08 
Last Updated: 2012-09-24 
Number of Patients: 214 
Recruitment Status: COMPLETED 
Condition: Sarcoma 

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: NCT00002462

Title: RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin’s Disease 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells.  PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin’s disease. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: bleomycin sulfate 
Start Date: 1989-09 
Last Updated: 2023-02-15 
Number of Patients: 615 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Lymphoma 

NCTID: NCT01367665

Title: STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma 
Study Summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity. 
Sponsor: Hoffmann-La Roche 
Intervention: vismodegib 
Start Date: 2011-07-01 
Last Updated: 2019-06-06 
Number of Patients: 1232 
Recruitment Status: COMPLETED 
Condition: Basal Cell Carcinoma 

NCTID: NCT02166788

Title: Evaluation of Groin Lymphadenectomy Extent For Metastatic Melanoma 
Study Summary: BACKGROUND: Spread of metastatic melanoma to the groin lymph nodes (LN) is a common event affecting about 350 people a year in Australia. Globally it has been shown that patients with involved groin LN, without proven pelvic LN disease on imaging receive 1 of 3 management strategies in equal proportions - inguinal lymphadenectomy (IL); ilio-inguinal lymphadenectomy (I-IL); or variable use of either depending on circumstances. Different experts have strong and polarised opinions favouring either IL or more extensive I-IL with existing cases series reporting conflicting data on best cancer outcomes. No high level evidence proves which operation is best. HYPOTHESIS: There will be no significant difference in DFS between patients having IL or I-IL, conditional on PET/CT scan showing no evidence of pelvic disease at the time of diagnosis of groin LN metastatic melanoma. AIMS: To provide a rational evidence base for management for melanoma to the groin LNs by randomly assessing the effect of each operation on DFS, distant DFS, overall survival (OS), morbidity - including early complications and longer-term rates of lymphedema as well as comprehensively assessed QOL. Also to clarify the reliability of PET/CT scans for staging pelvic LNs and evaluate any health economic benefits of I-IL over IL. TARGET POPULATION: To recruit 634 patients in 5 years. DESIGN: An Australian led, international, multi-centre, non-inferiority, phase III, prospective, randomised clinical trial comparing IL or I-IL for patients with metastatic melanoma to groin LNs and no evidence of pelvic disease on PET/CT. ENDPOINTS: DFS, Distant DFS, OS and QOL at 5 years. Accuracy of PET/CT for pelvic LN metastases.  OUTCOMES: International standardization of care, improved cancer outcomes, improved QOL for patients with groin metastatic melanoma. Proof of principle about extent of surgery when PET/CT is clear in adjacent LN areas, leading to clinical trials investigating management of other lymph node fields. 
Sponsor: Melanoma and Skin Cancer Trials Limited 
Intervention: Inguinal Lymphadenectomy 
Start Date: 2015-01 
Last Updated: 2022-04-07 
Number of Patients: 634 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Melanoma to the Groin Lymph Nodes 

NCTID: NCT02291289

Title: A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) 
Study Summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years. 
Sponsor: Hoffmann-La Roche 
Intervention: Cetuximab 
Start Date: 2015-04-17 
Last Updated: 2021-05-26 
Number of Patients: 609 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT05440916

Title: Palliative RadIotherapy of Multiple Metastatic Sites Before First Line of Systemic Therapy With Immune Checkpoint Inhibitors and Chemotherapy in Metastatic Non-Small-Cell Lung Cancer 
Study Summary: The study is designed as a non-randomized Phase 2 clinical intervention study. The study will include patients with disseminated Non-Small Cell Lung Carcinoma (NSCLC) which are eligible for first line of systemic treatment with immune checkpoint inhibitors and platinum-based chemotherapy (PDL1 less than 50%). Patients will receive palliative radiotherapy to multiple sites (2 to 5 sites) prior to systemic treatment.  Results of treatment will be compared to historical cohort of patients treated only with systemic therapy. 
Sponsor: University Medical Centre Maribor 
Intervention: Palliative Radiotherapy: 5 x 4Gy 
Start Date: 2022-07-14 
Last Updated: 2023-11-29 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Non-Small-Cell Lung 

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: NCT01045915

Title: Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma 
Study Summary: The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man. 
Sponsor: Onxeo 
Intervention: naked DNA coding for protein AMEP 
Start Date: 2010-07 
Last Updated: 2015-09-11 
Number of Patients: 5 
Recruitment Status: TERMINATED 
Condition: Melanoma 

NCTID: NCT03935763

Title: Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective 
Study Summary: A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective 
Sponsor: Servier Affaires Médicales 
Intervention: observational disease study 
Start Date: 2019-03-08 
Last Updated: 2023-04-12 
Number of Patients: 1000 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Colorectal 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: NCT01264952

Title: Treatment of Liver Metastases With Electrochemotherapy 
Study Summary: The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and II.  The study will include 10-15 patients with colorectal cancer with synchronous or metachronous liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm in the largest diameter.  Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and ultrasonography (US) in a monthly interval. Two or three month after the first operation the treated and untreated metastases will be resected and through histological analyses performed.  The secondary objectives of the trial are to quantify the impact of the treatment on the patient’s quality of life, tolerance to the therapy and suitability for larger study to be conducted. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Electrochemotherapy 
Start Date: 2008-11 
Last Updated: 2020-11-24 
Number of Patients: 16 
Recruitment Status: COMPLETED 
Condition: Liver Metastases 

NCTID: NCT00430352

Title: MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin’s Lymphoma. 
Study Summary: This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin’s lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. 
Sponsor: Hoffmann-La Roche 
Intervention: rituximab [MabThera/Rituxan] 
Start Date: 2006-09-04 
Last Updated: 2017-08-14 
Number of Patients: 545 
Recruitment Status: COMPLETED 
Condition: Non-Hodgkin’s Lymphoma 

NCTID: NCT01345526

Title: Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream 
Study Summary: The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment. 
Sponsor: Universitätsmedizin Mannheim 
Intervention: Reconval K1 Cream 
Start Date: 2011-04 
Last Updated: 2021-04-30 
Number of Patients: 124 
Recruitment Status: COMPLETED 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT01764009

Title: Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma 
Study Summary: The objective of the present trial is:  * to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. * to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP * to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP 
Sponsor: Onxeo 
Intervention: naked DNA coding for protein AMEP 
Start Date: 2012-06 
Last Updated: 2015-09-11 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Melanoma 

NCTID: NCT00868491

Title: Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer 
Study Summary: The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: docetaxel, cisplatin, 5-fluorouracil 
Start Date: 2008-03 
Last Updated: 2011-10-25 
Number of Patients: 30 
Recruitment Status: COMPLETED 
Condition: Head and Neck Cancer 

NCTID: NCT02425891

Title: A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) 
Study Summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody 
Start Date: 2015-06-23 
Last Updated: 2022-07-19 
Number of Patients: 902 
Recruitment Status: COMPLETED 
Condition: Triple Negative Breast Cancer 

NCTID: NCT05631379

Title: Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma 
Study Summary: This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Measurement of body composition with computed tomography (CT) 
Start Date: 2022-12-02 
Last Updated: 2022-12-07 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Retroperitoneal Sarcoma 

NCTID: NCT01702571

Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment 
Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2012-11-27 
Last Updated: 2022-04-04 
Number of Patients: 2185 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01307397

Title: A Study of Vemurafenib in Participants With Metastatic Melanoma 
Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Vemurafenib 
Start Date: 2011-03-01 
Last Updated: 2017-12-18 
Number of Patients: 3219 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT00006121

Title: Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy 
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 oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: oxaliplatin 
Start Date: 2000-05 
Last Updated: 2012-07-24 
Number of Patients: 18 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT05797831

Title: Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer 
Study Summary: This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.  The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo. 
Sponsor: Kartos Therapeutics, Inc. 
Intervention: Navtemadlin 
Start Date: 2023-07-17 
Last Updated: 2023-11-01 
Number of Patients: 268 
Recruitment Status: RECRUITING 
Condition: Endometrial Cancer 

NCTID: NCT01166542

Title: Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers 
Study Summary: The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck. 
Sponsor: Oncolytics Biotech 
Intervention: REOLYSIN 
Start Date: 2010-06 
Last Updated: 2014-11-05 
Number of Patients: 167 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Squamous Cell of the Head and Neck 

NCTID: NCT02308085

Title: Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer 
Study Summary: The best available evidence suggests that pregnancy after breast cancer does not increase a woman’s risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Endocrine therapy interruption 
Start Date: 2014-12-04 
Last Updated: 2023-03-16 
Number of Patients: 518 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT00781612

Title: A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies 
Study Summary: This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study. 
Sponsor: Genentech, Inc. 
Intervention: Docetaxel 
Start Date: 2008-10-16 
Last Updated: 2023-11-13 
Number of Patients: 720 
Recruitment Status: RECRUITING 
Condition: Neoplasm Metastasis 

NCTID: NCT01125566

Title: LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment 
Study Summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment 
Sponsor: Boehringer Ingelheim 
Intervention: BIBW 2992 
Start Date: 2010-06-22 
Last Updated: 2019-07-18 
Number of Patients: 508 
Recruitment Status: COMPLETED 
Condition: Breast 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: NCT01472653

Title: Treatment Selection According to Skin Reaction to Cetuximab 
Study Summary: The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: cisplatin 
Start Date: 2011-12 
Last Updated: 2011-12-13 
Number of Patients: 120 
Recruitment Status: UNKNOWN 
Condition: Head and Neck Cancer 

NCTID: NCT00049660

Title: Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer.  PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: capecitabine 
Start Date: 2002-09 
Last Updated: 2012-07-18 
Number of Patients: 47 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT00002529

Title: Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: cyclophosphamide 
Start Date: 1993-05 
Last Updated: 2013-04-04 
Number of Patients: 452 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04921553

Title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING) 
Study Summary: This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion.  This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications. 
Sponsor: Centre Leon Berard 
Intervention: Data collection and quality of life questionnaire 
Start Date: 2021-06-22 
Last Updated: 2021-08-02 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: Cancer 

NCTID: NCT00002777

Title: Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.  PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: exemestane 
Start Date: 1996-05 
Last Updated: 2012-07-02 
Number of Patients: 342 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05878977

Title: Biomarkers in Immunotherapy of Melanoma 
Study Summary: Background: Immunotherapy has been successful in treating advanced melanoma, but a large proportion of patients do not respond to the treatment with immune checkpoint inhibitors (ICIs). Preclinical and small cohort studies suggest biomarkers from the primary tumor, stool and body fluids as markers of response. This prospective study will evaluate gastrointestinal microbiome (bacterial spices and virome) composition and exosomal mRNA expression of PD-L1 and IFNγ correlation with radiological response rates to ICIs treatment of advanced melanoma patients. Methods: Patients treated with immune checkpoint inhibitors as a first line treatment for metastatic melanoma are recruted to the study. Stool samples are submitted before the start of treatment, at the 12 (+/-2) week and 28 (+/-4) week, and at the event ( such as, suspected disease progression/hyperprogressio, immune related adverse event (irAE), etc). Peripheral venous blood samples are taken additionaly at the same time points for cytologic and molecular tests. Histological material from the tumor tissue is obtained before the start of immunotherapy treatment. Primary objectives are to determine whether human gastrointestinal microbiome (bacterial and viral) and exosomal mRNA expression of PD-L1 and IFNγ predict response to treatment with PD-1 and CTLA-4 inhibitors and are associated with occurrence of irAE in patients with metastatic melanoma at different time points. Response is evaluated radiologically with imaging methods in accordance with the irRECIST criteria. Conclussion: Despite the great success of the treatment of metastatic melanoma with immunotherapy, there remains a significant proportion of patients who do not respond to treatment or who develop severe adverse events during treatment. Identification of novel predictive and prognostic biomarkers for immunotherapy treatment response is therefore necessary. This study is the first to combine and investigate multiple potential predictive and prognostic biomarkers and its dynamics. The results could serve for a better and multi-level understanding of the various factors influencing immunotherapy treatment. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Immune checkpoint inhibitor 
Start Date: 2022-10-05 
Last Updated: 2023-05-30 
Number of Patients: 150 
Recruitment Status: RECRUITING 
Condition: Metastatic Melanoma 

NCTID: NCT01358877

Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer 
Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). 
Sponsor: Hoffmann-La Roche 
Intervention: 5-Fluorouracil 
Start Date: 2011-11-08 
Last Updated: 2023-10-04 
Number of Patients: 4804 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04961996

Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) 
Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.  In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. 
Sponsor: Hoffmann-La Roche 
Intervention: Giredestrant 
Start Date: 2021-08-27 
Last Updated: 2023-11-18 
Number of Patients: 4200 
Recruitment Status: RECRUITING 
Condition: Early Breast Cancer 

NCTID: NCT00017095

Title: Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.  PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: filgrastim 
Start Date: 2001-03 
Last Updated: 2013-10-24 
Number of Patients: 1856 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01572038

Title: A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer 
Study Summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Docetaxel 
Start Date: 2012-06-01 
Last Updated: 2020-09-25 
Number of Patients: 1436 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT00014612

Title: Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: axillary lymph node dissection 
Start Date: 2001-02 
Last Updated: 2013-10-29 
Number of Patients: 4813 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00002555

Title: High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer 
Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with head and neck cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: cisplatin 
Start Date: 1994-02 
Last Updated: 2012-07-02 
Number of Patients: 338 
Recruitment Status: COMPLETED 
Condition: Head and Neck Cancer 

NCTID: NCT02807636

Title: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma 
Study Summary: A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2016-06-30 
Last Updated: 2023-06-09 
Number of Patients: 1213 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Urothelial Carcinoma 

NCTID: NCT00002528

Title: Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer 
Study Summary: RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.  PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: tamoxifen citrate 
Start Date: 1993-05 
Last Updated: 2013-04-04 
Number of Patients: 473 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT04740918

Title: A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) 
Study Summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2021-06-07 
Last Updated: 2023-11-18 
Number of Patients: 96 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT03148418

Title: A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A) 
Study Summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2017-09-20 
Last Updated: 2023-11-18 
Number of Patients: 382 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cancer 

NCTID: NCT01461928

Title: A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab 
Study Summary: This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin’s lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter <math display="block">mg/m\^2</math> intravenously <math display="block">IV</math> in Cycle 1, then 1400 mg subcutaneous <math display="block">SC</math> every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Chemotherapy (Induction Period) 
Start Date: 2011-12-20 
Last Updated: 2019-08-06 
Number of Patients: 692 
Recruitment Status: COMPLETED 
Condition: Non-Hodgkin’s Lymphoma 

NCTID: NCT00066378

Title: Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells.  PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: anastrozole 
Start Date: 2003-05 
Last Updated: 2013-10-24 
Number of Patients: 71 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01243632

Title: Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment 
Study Summary: Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: Prolonged 6-hr infusion of gemcitabine 
Start Date: 2002-12 
Last Updated: 2010-11-18 
Number of Patients: 78 
Recruitment Status: COMPLETED 
Condition: Malignant Pleural Mesothelioma 

NCTID: NCT00400478

Title: A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13 
Study Summary: This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.  Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited. 
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie 
Intervention: Rituximab 
Start Date: 2006-01 
Last Updated: 2016-05-26 
Number of Patients: 683 
Recruitment Status: COMPLETED 
Condition: Diffuse Large B-Cell Lymphoma (DLBCL) 

NCTID: NCT02031458

Title: A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer 
Study Summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2014-01-22 
Last Updated: 2020-01-06 
Number of Patients: 667 
Recruitment Status: COMPLETED 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT00005584

Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin’s lymphoma.  PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin’s lymphoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: bleomycin sulfate 
Start Date: 1998-10 
Last Updated: 2023-02-15 
Number of Patients: 1649 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Lymphoma 

NCTID: NCT03337724

Title: A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer 
Study Summary: This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Ipatasertib 
Start Date: 2018-01-06 
Last Updated: 2023-02-08 
Number of Patients: 580 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00293124

Title: Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors 
Study Summary: The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data.  Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries. 
Sponsor: Central European Cooperative Oncology Group 
Intervention: Glivec 
Start Date: 2004-03 
Last Updated: 2015-08-13 
Number of Patients: 125 
Recruitment Status: COMPLETED 
Condition: Gastrointestinal Stromal Tumors 

NCTID: NCT03466957

Title: Individual Approach in Gynecological Cancer Brachytherapy 
Study Summary: MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of gynecological cancers. Commercially available standard MRI compatible applicators for BT of gynecological cancers don’t always allow for optimal target volume coverage. Three-dimensional (3D) printed technology enables versatile possibilities of improvement of standard applicators and development of novel applicators with better coverage of the target volume. The purpose of this study is to implement and assess 3D printing technology as an instrument for designing and manufacturing applicators for individualized BT of gynecological cancers. 
Sponsor: Institute of Oncology Ljubljana 
Intervention: 3D printed applicator 
Start Date: 2016-05 
Last Updated: 2018-03-15 
Number of Patients: 13 
Recruitment Status: UNKNOWN 
Condition: Cancer 

NCTID: NCT04148911

Title: A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer 
Study Summary: Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2019-12-17 
Last Updated: 2023-09-21 
Number of Patients: 184 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Triple-Negative Breast Cancer 

NCTID: NCT06007001

Title: Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA 
Study Summary: The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients’ empowerment.  The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers.  The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care.  Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care.  PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients’ experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care. 
Sponsor: Sciensano 
Intervention: Telemedicine 
Start Date: 2023-09-15 
Last Updated: 2023-08-23 
Number of Patients: 354 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Cancer 

NCTID: NCT02869399

Title: Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention 
Study Summary: This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed to be in complete remission at month 3 after curative treatment are considered for this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary intervention in addition to standard recommendations and a control arm (arm B) including only standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries. 
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 
Intervention: dietary intervention in addition to standard recommendations 
Start Date: 2015-11 
Last Updated: 2023-03-13 
Number of Patients: 94 
Recruitment Status: COMPLETED 
Condition: Cancer of Head and Neck 

NCTID: NCT02129699

Title: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy 
Study Summary: The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called “non small cell lung cancer” (NSCLC) that has spread to other parts of the body. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Denosumab 
Start Date: 2015-01-06 
Last Updated: 2020-08-11 
Number of Patients: 514 
Recruitment Status: COMPLETED 
Condition: Lung Cancer Non-small Cell Stage IV

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