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NCT01599559 · ClinicalTrials.gov registry record · NA
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
A NA study of Primary Mediastinal B-cell Lymphoma, sponsored by International Extranodal Lymphoma Study Group (IELSG).
- Active
- Registry status
- NA
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT01599559 is a NA study of Primary Mediastinal B-cell Lymphoma that is active but no longer recruiting, run by International Extranodal Lymphoma Study Group (IELSG). The registered enrollment target is 540 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT01599559, a NA study of Primary Mediastinal B-cell Lymphoma, is active but no longer recruiting, sponsored by International Extranodal Lymphoma Study Group (IELSG).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
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trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active.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.
Conditions Studied
Interventions
- OTHER observation
- RADIATION 3D-Conformal Radiotherapy (3D-CRT)
Study Locations (20)
Other
- Centro de Hematologia y Oncologia Pavlovsky - Buenos Aires
- Princess Margaret Hospital - Toronto
- Ruijin Hospital - Shanghai
- Faculty Hospital Brno - Brno
- University Hospital - Hradec Králové
- Faculty Hospital Kralovske Vinohrady - Prague
- General University Hospital - Prague
- University of Duisburg-Essen, Campus Essen - Essen
- A.O. SS. Antonio e Biagio e Cesare Arrigo - Alessandria
- Clinica di Ematologia Ospedali Riuniti "Umberto I" - Ancona
- Centro di Riferimento Oncologico - Aviano - Aviano
- A.O.U Policlinico Consorziale di Bari - Bari
- Bari IRCCS Istituto Tumori - Bari
- Ospedale Mons. Dimiccoli - Barletta
- Ospedale Papa Giovanni Xxiii - Bergamo
- Sant'Orsola Malpighi - Bologna
- Comprensorio Sanitario di Bolzano - Bolzano
Kentucky
- Norton Cancer Institute - Louisville
Minnesota
- Mayo Clinil Rocheser - Rochester
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2012-10 |
| Est. Completion | 2029-12-17 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01599559
The ClinicalTrials.gov registry entry for NCT01599559 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International Extranodal Lymphoma Study Group (IELSG), which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Mediastinal B-cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which observation is the first listed.
NCT01599559 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, Kentucky, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01599559 about?
NCT01599559 is a clinical study titled "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". 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 chemoimmunother...
What is the current status of trial NCT01599559?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 540 participants. The study started on 2012-10. Estimated completion is 2029-12-17.
What conditions does trial NCT01599559 study?
This clinical trial studies the following conditions: Primary Mediastinal B-cell Lymphoma.
What interventions are being tested in trial NCT01599559?
The interventions under investigation include: observation (OTHER), 3D-Conformal Radiotherapy (3D-CRT) (RADIATION).
Who is sponsoring clinical trial NCT01599559?
This trial is sponsored by International Extranodal Lymphoma Study Group (IELSG), which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01599559 being conducted?
This trial has 20 study locations across Kentucky, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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