Trials (Centro di Riferimento Oncologico di Aviano): Difference between revisions
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Go back to [[Centro di Riferimento Oncologico di Aviano]] page | Go back to [[Centro di Riferimento Oncologico di Aviano]] page | ||
=== Trials: How to participate === | |||
'''Contact information:''' [https://www.cro.it/it/studi-clinici/ Click here to access]. | |||
'''NCTID''': NCT00002903 | '''NCTID''': NCT00002903 | ||
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'''Recruitment Status''': ACTIVE_NOT_RECRUITING | '''Recruitment Status''': ACTIVE_NOT_RECRUITING | ||
'''Condition''': MALT Lymphoma | '''Condition''': MALT Lymphoma | ||
<span style="display:none">hasCancerType::C00-D48: All neoplasms</span> | |||
<span style="display:none">hasCancerType::C00-C97: All cancer types</span> | |||
<span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span> | |||
<span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span> | |||
<span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span> | |||
<span style="display:none">hasCancerType::C40-C41: Bone cancers</span> | |||
<span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span> | |||
<span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span> | |||
<span style="display:none">hasCancerType::C50: Breast cancer</span> | |||
<span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span> | |||
<span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span> | |||
<span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span> | |||
<span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span> | |||
<span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span> | |||
<span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span> | |||
<span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span> | |||
<span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span> | |||
<span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span> | |||
<span style="display:none">hasCancerType::D10-D36: Benign tumour</span> | |||
<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span> | |||
<span style="display:none">hasCancerType::unknown</span> | |||
<span style="display:none">isTrial</span> | |||
Latest revision as of 11:06, 15 December 2025
Go back to Centro di Riferimento Oncologico di Aviano page
Trials: How to participate[edit | edit source]
Contact information: Click here to access.
NCTID: NCT00002903
Title: Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer 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 docetaxel in treating patients with recurrent or refractory germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: docetaxel Start Date: 1995-07 Last Updated: 2012-07-02 Number of Patients: 25 Recruitment Status: COMPLETED Condition: Extragonadal Germ Cell Tumor
NCTID: NCT00719797
Title: Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens given together with bevacizumab to see how well they work as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: bevacizumab Start Date: 2008-07 Last Updated: 2015-03-11 Number of Patients: 509 Recruitment Status: COMPLETED Condition: Colorectal 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: NCT01599559
Title: Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma Study Summary: Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy). Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation. Patients that at the end of conventional treatment of chemoimmunotherapy have a negative PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to two different treatment groups: one treatment group will receive the radiation treatment, and the other treatment group will receive careful observation. The trial is planned according to a non-inferiority design aimed at demonstrating that progression free survival after the experimental treatment (observation) is not worse than after the standard comparator (mediastinal irradiation.Participation in this study could spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative) radiation therapy that may be unnecessary. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: observation Start Date: 2012-10 Last Updated: 2023-10-19 Number of Patients: 540 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Primary Mediastinal B-cell Lymphoma
NCTID: NCT03596866
Title: A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer Study Summary: Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later. Sponsor: Takeda Intervention: Brigatinib Start Date: 2019-04-19 Last Updated: 2023-05-18 Number of Patients: 248 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: ALK+ Advanced NSCLC
NCTID: NCT04622319
Title: A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) Study Summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-8201a Start Date: 2020-12-04 Last Updated: 2023-11-07 Number of Patients: 1600 Recruitment Status: RECRUITING Condition: HER2-Positive Primary 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: NCT03635567
Title: Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) Study Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-10-25 Last Updated: 2023-11-14 Number of Patients: 617 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cervical Cancer
NCTID: NCT00003419
Title: Antiviral Therapy in Treating Patients With Slowly Progressing HIV-Related Kaposi’s Sarcoma Study Summary: RATIONALE: HIV virus is found in the lesions of most patients with Kaposi’s sarcoma, and may have a role in causing Kaposi’s sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi’s sarcoma. PURPOSE: This phase II trial is studying how well antiviral therapy works in treating patients with slowly progressing HIV-related Kaposi’s sarcoma. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: antiviral therapy Start Date: 1998-06 Last Updated: 2013-09-20 Number of Patients: 25 Recruitment Status: UNKNOWN Condition: Sarcoma
NCTID: NCT04581187
Title: An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies Study Summary: This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient’s rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Quality of life assessment Start Date: 2020-12-02 Last Updated: 2021-05-17 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Hematologic Malignancies
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-29 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT00263822
Title: Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Study Summary: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: erlotinib hydrochloride Start Date: 2005-09 Last Updated: 2013-08-27 Number of Patients: 835 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT04383119
Title: Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma Study Summary: Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype. Sponsor: Italian Sarcoma Group Intervention: Trabectedin Start Date: 2021-10-29 Last Updated: 2023-09-13 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Leiomyosarcoma of Ovary
NCTID: NCT02227433
Title: Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease. Study Summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL. BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007). Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression. Study Objectives Primary: • To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL). Secondary: * To assess duration of tumor control, including duration of response and progression-free survival * To assess survival * To assess the safety and tolerability of BV Additional: • To assess disease-related symptoms Study Population Eligible patients are those with first relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, kidney, and liver function. Eligible patients must not previously have been treated with BV, patients must not have congestive heart failure, known cerebral/meningeal disease, or any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to first study dose. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Brentuximab Vedotin Start Date: 2013-02-04 Last Updated: 2020-12-22 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT05966233
Title: R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma Study Summary: Prospective, multicenter, open label, phase II randomized clinical trial in DLBCL patients relapsed or refractory to first line R-chemo, aged 18-70 years and candidate to autologous transplant. Patients will be randomized 1:1 to received 4 cycles of R-DHAP or R-DHAP plus Polatuzumab Vedotin as induction treatment plus autologous transplant. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: R-DHAP Start Date: 2023-10 Last Updated: 2023-08-01 Number of Patients: 150 Recruitment Status: NOT_YET_RECRUITING Condition: Diffuse Large B Cell Lymphoma Refractory
NCTID: NCT04821622
Title: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Study Summary: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. Sponsor: Pfizer Intervention: talazoparib plus enzalutamide Start Date: 2021-05-12 Last Updated: 2023-11-22 Number of Patients: 599 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT05929222
Title: Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi Study Summary: Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinotuzumab. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Radiotherapy Start Date: 2024-01 Last Updated: 2023-09-08 Number of Patients: 190 Recruitment Status: NOT_YET_RECRUITING Condition: Follicular Lymphoma
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: NCT02360579
Title: Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma Study Summary: Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen. Sponsor: Iovance Biotherapeutics, Inc. Intervention: Lifileucel Start Date: 2015-09 Last Updated: 2023-07-12 Number of Patients: 178 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Melanoma
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: NCT04362072
Title: Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer Study Summary: The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment. Participants will take part in this study for up to approximately 4 years, depending on when the study is completed and how their cancer responds to the study treatment. They will take lorlatinib orally (by mouth) once daily. Participants will visit the study site about every six weeks to meet with the study team. During these visits, the study team will monitor the safety and effects of lorlatinib. Sponsor: Pfizer Intervention: Lorlatinib Start Date: 2020-09-29 Last Updated: 2023-07-07 Number of Patients: 71 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma
NCTID: NCT00003888
Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 1999-04 Last Updated: 2018-07-09 Number of Patients: 359 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT00005887
Title: Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: efaproxiral Start Date: 2000-02 Last Updated: 2021-08-23 Number of Patients: NA Recruitment Status: COMPLETED Condition: Metastatic Cancer
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: NCT05300282
Title: Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin’s Lymphoma Patients Study Summary: The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): # arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. # arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients’ prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Atezolizumab Start Date: 2022-08-03 Last Updated: 2023-09-15 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Hodgkin’s Lymphoma
NCTID: NCT03713593
Title: Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) Study Summary: The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: lenvatinib Start Date: 2018-12-31 Last Updated: 2023-07-24 Number of Patients: 794 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Hepatocellular
NCTID: NCT02566993
Title: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer Study Summary: Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line. Sponsor: PharmaMar Intervention: Lurbinectedin (PM01183) Start Date: 2016-08-30 Last Updated: 2021-10-28 Number of Patients: 613 Recruitment Status: COMPLETED Condition: 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: NCT03768505
Title: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL) Study Summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy Sponsor: MEI Pharma, Inc. Intervention: Zandelisib (ME-401) Start Date: 2019-06-25 Last Updated: 2023-05-09 Number of Patients: 169 Recruitment Status: TERMINATED Condition: Follicular Lymphoma (FL)
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: NCT05058404
Title: Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma Study Summary: FIL_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d’Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Immunochemotherapy regimen: Rituximab-bendamustine (Arm A) Start Date: 2021-12-01 Last Updated: 2023-03-09 Number of Patients: 602 Recruitment Status: RECRUITING Condition: Follicular Lymphoma
NCTID: NCT01792726
Title: A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer. Study Summary: TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial. Eligible patients are those with a higher risk of local recurrence after breast conserving surgery. After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually. The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life. Sponsor: University College, London Intervention: Boost to the tumour bed Start Date: 2013-06 Last Updated: 2019-07-12 Number of Patients: 1796 Recruitment Status: UNKNOWN Condition: Early Breast Cancer
NCTID: NCT02767804
Title: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients Study Summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor. Sponsor: Xcovery Holding Company, LLC Intervention: X-396 (ensartinib) Start Date: 2016-06 Last Updated: 2023-02-09 Number of Patients: 290 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT00002904
Title: Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: trabectedin Start Date: 1996-02 Last Updated: 2012-07-02 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT00707304
Title: Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer Study Summary: The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens. Sponsor: Agennix Intervention: Talactoferrin Start Date: 2008-11 Last Updated: 2012-08-21 Number of Patients: 742 Recruitment Status: COMPLETED Condition: Non Small Cell Lung Cancer
NCTID: NCT05696626
Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Study Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. Sponsor: Sermonix Pharmaceuticals Inc. Intervention: Lasofoxifene in combination with abemaciclib Start Date: 2023-10-31 Last Updated: 2023-11-14 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT06055517
Title: Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR) Study Summary: Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: Pulsed low dose-rate radiotherapy (pLDRT) Start Date: 2023-05-26 Last Updated: 2023-09-26 Number of Patients: 29 Recruitment Status: RECRUITING Condition: Glioma
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT04527991
Title: Study of Sacituzumab Govitecan-hziy (IMMU-132) Versus Treatment of Physician’s Choice in Participants With Metastatic or Locally Advanced Unresectable Urothelial Cancer Study Summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician’s choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2021-01-13 Last Updated: 2023-06-22 Number of Patients: 696 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced or Metastatic Unresectable Urothelial Cancer
NCTID: NCT06008691
Title: A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice Study Summary: This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: “novel” MAB (alone or in combination) Start Date: 2023-10 Last Updated: 2023-08-23 Number of Patients: 1500 Recruitment Status: NOT_YET_RECRUITING Condition: Non-Hodgkin Lymphoma, B-cell
NCTID: NCT00039039
Title: Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable stage III non-small cell lung cancer. Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Intervention: carboplatin Start Date: 2000-02 Last Updated: 2013-12-18 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: Lung Cancer
NCTID: NCT02825420
Title: Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients Study Summary: Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug Sponsor: PharmaMar Intervention: trabectedin Start Date: 2015-07-28 Last Updated: 2021-10-29 Number of Patients: 220 Recruitment Status: COMPLETED Condition: Relapsed Ovarian Cancer
NCTID: NCT04172220
Title: Does Type of Anesthesia Influence Inflammation Change After Breast Surgery? Study Summary: The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state. This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: Midazolam Start Date: 2019-10-31 Last Updated: 2023-10-30 Number of Patients: 68 Recruitment Status: COMPLETED Condition: Breast Cancer Female
NCTID: NCT00002905
Title: Combination Chemotherapy in Treating Patients With HIV-Related 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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with HIV-related non-Hodgkin’s lymphoma that has relapsed or has not responded to chemotherapy. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: cyclophosphamide Start Date: 1995-06 Last Updated: 2013-09-20 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT02793050
Title: Retrospective Study of Trabectedin in Soft Tissue Sarcomas Study Summary: This is an independent, observational, retrospective post marketing study on the use of trabectedin in a clinical setting. A data collection on the clinical use of the drug will help to improve knowledge and might contribute to optimize the clinical use of the drug. Sponsor: Italian Sarcoma Group Intervention: Trabectedin Start Date: 2016-06-15 Last Updated: 2019-05-10 Number of Patients: 510 Recruitment Status: COMPLETED Condition: Sarcoma, Soft Tissue
NCTID: NCT02500043
Title: Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer Study Summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. Sponsor: Taiho Oncology, Inc. Intervention: TAS-102 Start Date: 2016-02-24 Last Updated: 2021-09-16 Number of Patients: 507 Recruitment Status: COMPLETED Condition: Refractory Metastatic Gastric Cancer
NCTID: NCT02829437
Title: Observational Study on Endometrial Stromal Tumors Study Summary: Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST) Sponsor: Italian Sarcoma Group Intervention: Treatment for EST Start Date: 2016-10 Last Updated: 2023-10-04 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Endometrial Stromal Tumors
NCTID: NCT01389414
Title: Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma Study Summary: This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy. Sponsor: Prof. Massimo Aglietta Intervention: Panitumumab plus GEMOX chemotherapy Start Date: 2010-05 Last Updated: 2015-05-28 Number of Patients: 89 Recruitment Status: COMPLETED Condition: Biliary Carcinoma
NCTID: NCT00090025
Title: XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Study Summary: The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors. Sponsor: Helsinn Healthcare SA Intervention: becatecarin Start Date: 2004-09 Last Updated: 2009-01-14 Number of Patients: 248 Recruitment Status: TERMINATED Condition: Biliary Tract Cancer
NCTID: NCT04332822
Title: A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma Study Summary: This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026. Sponsor: Nordic Lymphoma Group Intervention: R-pola-mini-CHP Start Date: 2020-08-19 Last Updated: 2021-07-09 Number of Patients: 200 Recruitment Status: RECRUITING Condition: DLBCL
NCTID: NCT03697512
Title: MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas Study Summary: Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Ibrutinib Start Date: 2019-09-27 Last Updated: 2023-05-10 Number of Patients: 175 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Marginal Zone Lymphoma
NCTID: NCT00052312
Title: Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2002-09 Last Updated: 2012-09-24 Number of Patients: 141 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT04915248
Title: Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients. Study Summary: It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Daratumumab Start Date: 2022-07-11 Last Updated: 2023-10-11 Number of Patients: 28 Recruitment Status: RECRUITING Condition: Plasmablastic Lymphoma
NCTID: NCT04659551
Title: Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients Study Summary: Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. 2-weekly for 8 courses. GnRH analogues are started concomitantly with chemotherapy and maintained until the completion of neoadjuvant treatment. Sponsor: Istituto Oncologico Veneto IRCCS Intervention: Epirubicin Start Date: 2017-10-05 Last Updated: 2020-12-09 Number of Patients: 43 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01925612
Title: Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL) Study Summary: This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups. The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin. The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2013-08 Last Updated: 2018-06-21 Number of Patients: 87 Recruitment Status: TERMINATED Condition: Lymphoma, B-cell
NCTID: NCT00086866
Title: Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery Study Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: D1/3-MAGE-3-His fusion protein Start Date: 2004-05 Last Updated: 2015-02-10 Number of Patients: 165 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT03387592
Title: CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas Study Summary: This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are primary objectives, secondary objectives are Disease control rate (OS), Progression Free Survival (PFS), quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose. Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Intervention: CPT-11 Start Date: 2017-03-06 Last Updated: 2021-02-26 Number of Patients: 112 Recruitment Status: UNKNOWN Condition: Neuroendocrine Carcinoma
NCTID: NCT04442412
Title: Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy Study Summary: This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm). All patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Vitamin D3 (Cholecalciferol) Start Date: 2021-03-23 Last Updated: 2022-08-26 Number of Patients: 430 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT00499265
Title: Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. WX-671 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with WX-671 may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well gemcitabine works when given together with WX-671 or when given alone in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery. Sponsor: Heidelberg Pharma AG Intervention: gemcitabine hydrochloride Start Date: 2007-04 Last Updated: 2012-03-29 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT02295930
Title: Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient Study Summary: This is a phase II randomized study of 4-months induction first-line chemotherapy with FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients affected by KRAS wild type (wt) mCRC. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: folfoxiri+cetuximab+surgery+cetuximab Start Date: 2011-10 Last Updated: 2015-03-12 Number of Patients: 143 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT03420742
Title: A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors Study Summary: The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam. Sponsor: Takeda Intervention: Midazolam Start Date: 2019-06-26 Last Updated: 2023-01-27 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
NCTID: NCT03031483
Title: Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma Study Summary: Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: clarithromycin and lenalidomide Start Date: 2017-04-03 Last Updated: 2022-11-07 Number of Patients: 44 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
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: NCT02293785
Title: GREAT - Good Response With Appropriate Treatment Study Summary: The symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. The pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic. The use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. Some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist. Several clinical studies have demonstrated that the association oxycodone-naloxone (OXN), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Oxycodone-Naloxone Start Date: 2014-11 Last Updated: 2016-03-21 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Cancer Pain
NCTID: NCT01125085
Title: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiation in Patients With Multiple Brain Metastases From Solid Tumors Study Summary: The aim of this Proof of Concept study is to determine the therapeutic potential of the L19SIP antibody, labeled with the radionuclide 131I in combination with external beam radiation, for the treatment of patients with multiple brain metastases following the promising results with this agent in previous clinical studies. The L19SIP antibody is a fully human antibody, capable of preferential localization around tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature in most aggressive types of cancer. The presented study follows a Phase I and a subsequent Phase I/II dose finding and efficacy study with the same agent in patients with a variety of cancers where 131I-L19SIP had shown an excellent tolerability and therapeutic benefit for some patients enrolled in the study. Sponsor: Philogen S.p.A. Intervention: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT) Start Date: 2009-10 Last Updated: 2014-02-25 Number of Patients: 32 Recruitment Status: COMPLETED Condition: Brain Metastases From Solid Tumors
NCTID: NCT00003261
Title: Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma 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 chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: methotrexate Start Date: 1997-05 Last Updated: 2013-09-20 Number of Patients: 14 Recruitment Status: UNKNOWN Condition: Lymphoma
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: NCT01904253
Title: A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy Study Summary: The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102. Sponsor: Taiho Oncology, Inc. Intervention: TAS-102 Start Date: 2013-07 Last Updated: 2014-07-14 Number of Patients: 18 Recruitment Status: TERMINATED Condition: Small Cell Lung Cancer (SCLC)
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: NCT01737177
Title: Bendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL Study Summary: This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Bendamustine, Lenalidomide, Rituximab Start Date: 2012-07-31 Last Updated: 2018-03-09 Number of Patients: 42 Recruitment Status: COMPLETED Condition: Mantle Cell Lymphoma
NCTID: NCT03773510
Title: Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin Study Summary: Two arm, randomized, open-label study, to determine the best time to secondary resistance between responding patients who discontinue treatment and resumed Trabectedin at the time of progression versus patients who continued treatment until progression. T Sponsor: Italian Sarcoma Group Intervention: Trabectedin discontinuation Start Date: 2019-02-28 Last Updated: 2019-05-13 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Leiomyosarcoma
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: NCT00003262
Title: Combination Chemotherapy in Treating Patients With Hodgkin’s Disease and HIV Infection 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 drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin’s disease and HIV infection. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: bleomycin sulfate Start Date: 1997-05 Last Updated: 2013-09-20 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT05015010
Title: Alectinib in Neo-adjuvant Treatment of Stage III NSCLC Study Summary: Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery. Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica Intervention: Alectinib Start Date: 2021-05-20 Last Updated: 2022-10-03 Number of Patients: 33 Recruitment Status: RECRUITING Condition: Non Small Cell Lung 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: NCT03804372
Title: The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide Study Summary: In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Rituximab Start Date: 2020-07-07 Last Updated: 2022-01-04 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Large-B-cell Diffuse Lymphoma
NCTID: NCT05977673
Title: Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy Study Summary: This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Tislelizumab Start Date: 2023-12 Last Updated: 2023-11-24 Number of Patients: 28 Recruitment Status: NOT_YET_RECRUITING Condition: Hodgkin Lymphoma
NCTID: NCT02926196
Title: Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab Study Summary: Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients: * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy. Sponsor: Istituto Oncologico Veneto IRCCS Intervention: MSB0010718C Start Date: 2016-06-17 Last Updated: 2023-10-31 Number of Patients: 474 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT00470236
Title: Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast Study Summary: Hypotheses: # The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). # The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. # A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization. Overall Objectives: # To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. # To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity. Sponsor: Trans Tasman Radiation Oncology Group Intervention: Standard WB fractionation Start Date: 2007-06 Last Updated: 2023-03-22 Number of Patients: 1608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Ductal, Breast
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: NCT05934084
Title: Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors Study Summary: This is a prospective randomized open-label, multicenter, 2-arm study to assess the role of healthy LifeStyle implemented Survivorship Care Plan (LS-SCP) in modifying the Quality of Life (QoL) in a population of long-term lymphoma survivors (in remission for a minimum 3 years since the last treatment and a maximum of 10 years). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Lifestyles Implemented-Survivorship Care Plan (LS-SCP) Start Date: 2023-08-01 Last Updated: 2023-07-06 Number of Patients: 552 Recruitment Status: NOT_YET_RECRUITING Condition: Classical Hodgkin Lymphoma
NCTID: NCT00003028
Title: MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: sabarubicin Start Date: 1997-04 Last Updated: 2012-07-02 Number of Patients: 5 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT04447118
Title: Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy Study Summary: This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy. Sponsor: Jiangsu HengRui Medicine Co., Ltd. Intervention: Pyrotinib Start Date: 2020-09-11 Last Updated: 2023-03-08 Number of Patients: 151 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-squamous NSCLC
NCTID: NCT04502394
Title: Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy) Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2021-02-23 Last Updated: 2022-08-04 Number of Patients: 84 Recruitment Status: RECRUITING Condition: Diffuse Large B Cell Lymphoma
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: NCT03535740
Title: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib Study Summary: The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors <math display="block">RECIST</math>), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib. Sponsor: Ariad Pharmaceuticals Intervention: Brigatinib Start Date: 2019-01-31 Last Updated: 2023-08-25 Number of Patients: 103 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: ALK-positive Advanced NSCLC
NCTID: NCT02247544
Title: Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma Study Summary: This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth. Another objective is to investigate this peculiar benefit of trabectedin in typical retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making in the management of retroperitoneal sarcomas Sponsor: Italian Sarcoma Group Intervention: Trabectedin Start Date: 2014-03 Last Updated: 2021-11-01 Number of Patients: 105 Recruitment Status: COMPLETED Condition: Liposarcoma
NCTID: NCT03838744
Title: Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments. Study Summary: Phase II study in patient with advanced Soft Tissue Sarcoma (STS) patients who have already received or are not suitable, for a doxorubicin-based treatment. Sponsor: Italian Sarcoma Group Intervention: Standard arm: Trabectedin in monotherapy Start Date: 2020-05-26 Last Updated: 2023-09-13 Number of Patients: 126 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Soft Tissue Sarcoma
NCTID: NCT01732913
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Placebo Start Date: 2013-01-16 Last Updated: 2018-11-16 Number of Patients: 295 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT00003013
Title: Chemotherapy Plus Surgery in Treating Women With Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy 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 study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: CMF regimen Start Date: 1996-10 Last Updated: 2013-09-17 Number of Patients: 450 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02737501
Title: ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants Study Summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS). Sponsor: Ariad Pharmaceuticals Intervention: Brigatinib Start Date: 2016-05-26 Last Updated: 2021-08-20 Number of Patients: 275 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT03230734
Title: Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer Study Summary: Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms: * Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of progression (the second step is optional according to clinical evolution of disease) * Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of progression (the second step is optional according to clinical evolution of disease). Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Intervention: Radium-223 Start Date: 2017-09-01 Last Updated: 2023-05-30 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Metastatic Castration-resistant Prostate Cancer
NCTID: NCT01117441
Title: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia Study Summary: Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: * Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? * Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? * High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: * Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? * T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? * HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase “MRD Non-Responders”: Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? * Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? * What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol? Sponsor: University Hospital Schleswig-Holstein Intervention: PEG-L-asparaginase Start Date: 2010-06 Last Updated: 2022-05-24 Number of Patients: 6136 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT03106324
Title: A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant Study Summary: This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months’ post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed. Sponsor: Celgene Intervention: Revlimid (lenalidomide) Start Date: 2017-03-31 Last Updated: 2022-06-02 Number of Patients: 911 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT05814224
Title: Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA Study Summary: The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy. Sponsor: Centro di Riferimento Oncologico - Aviano Intervention: Liquid biopsy and CT scan Start Date: 2018-05-22 Last Updated: 2023-04-14 Number of Patients: 164 Recruitment Status: RECRUITING Condition: Hormone Receptor Positive Breast Carcinoma
NCTID: NCT01265901
Title: IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma Study Summary: The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters. Sponsor: Immatics Biotechnologies GmbH Intervention: Sunitinib Start Date: 2010-12 Last Updated: 2017-10-12 Number of Patients: 339 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Carcinoma
NCTID: NCT01808599
Title: Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma Study Summary: Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma). Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Chlorambucil Start Date: 2013-12 Last Updated: 2023-05-18 Number of Patients: 112 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: MALT Lymphoma
