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
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| ClinicalTrials.gov Identifier: NCT01599559 |
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Recruitment Status :
Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : October 19, 2023
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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trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active.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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Mediastinal B-cell Lymphoma | Other: observation Radiation: 3D-Conformal Radiotherapy (3D-CRT) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 540 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | IELSG37: A Randomized, Open-label, Multicentre, Two-arm 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 (PMLBCL) |
| Actual Study Start Date : | October 2012 |
| Actual Primary Completion Date : | June 17, 2022 |
| Estimated Study Completion Date : | December 17, 2029 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: observation
Follow up visits are scheduled from randomization. Patients will be seen at 3-months intervals for 24 months, then every 6 months until 5 years from randomization.
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Other: observation
observation |
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Active Comparator: mediastinal irradiation
Radiotherapy will be delivered in this phase III protocol, as alternative to observation, as consolidation treatment in patients achieving a CR status (PET/CT scan negative) at the end of R-chemotherapy, with a total dose of 30 Gy.
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Radiation: 3D-Conformal Radiotherapy (3D-CRT)
Radiation treatment should start within 6-8 weeks after the end of chemotherapy. |
- Progression free survival (PFS) [ Time Frame: 30 months from the randomization ]
The primary outcome endpoint will be Progression Free Survival (PFS) in patients PET-negative after R-chemotherapy.
Failure events for PFS are progression (defined as an increase in size of existing masses or the development of new sites of disease using the same radiological investigations CT or PET/CT and/or MRI - as for the pre-chemotherapy assessment) or death from any cause.
- Overall survival (OS) [ Time Frame: 5 years from registration ]OS is defined as the time from registration until death as a result of any cause until five years from registration
- Long term toxicity [ Time Frame: 10 years from registration ]Reporting of any adverse event which is judged in the opinion of investigator to be possibly treatment-related up to 10 years from randomization (including all cardiac and pulmonary events, relapses and second cancers and deaths)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previously untreated primary mediastinal diffuse large B-cell lymphoma, CD20 positive.
- Patients must have histological confirmation of the diagnosis (it is recommended that the immunohistochemical panel includes: CD45, CD20, CD30, CD15, CD10, BCL6, BCL2, MUM-1), and in addition have a dominant mass within the anterior mediastinum.
- No evidence of extranodal disease outside the chest including spleen and bone marrow.
- Age at least 18 years.
- Fit to receive chemotherapy and radiotherapy with curative intent.
- Patients will be eligible if the treatment phase consisting in a Rituximab combined with any anthracycline-containing chemotherapy regimen without consolidation with autologous stem cell support (e.g., 6 cycles of CHOP14-21, DA-EPOCH, Mega-CHOP or 12 weeks of VACOP-B or MACOP-B).
- At least 6 courses of Rituximab should be administered
- Able and willing to give informed consent, and to undergo staging including PET scanning
- Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
- Histological diagnostic material available for review.
Exclusion Criteria:
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.
- Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- Known HIV-positive serology.
- Pregnant or lactating women.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599559
Show 85 study locations
| Study Chair: | Maurizio Martelli, MD | Università La Sapienza (Rome - Italy) | |
| Study Chair: | Andrew J Davies, MD | University of Southampton (UK) | |
| Study Chair: | Mary Gospodarowicz, MD | Princess Margaret Hospital Toronto (Canada) | |
| Study Chair: | Sally F Barrington, MD | St. Thomas' - London (UK) | |
| Study Chair: | Alberto Biggi, MD | AO S. Croce e Carle, Cuneo (Italia) | |
| Study Chair: | Annibale Versari, MD | S.Maria Nuova Hospital, Reggio Emilia (Italia) | |
| Study Chair: | Gianni Ciccone, MD | CPO Torino (Italy) | |
| Study Chair: | Stèphane Chauvie, MD | AO S. Crtoce e Carle - Cuneo (Italy) | |
| Study Chair: | Luca Ceriani, MD | IOSI - Bellinzona (Switzerland) |
| Responsible Party: | International Extranodal Lymphoma Study Group (IELSG) |
| ClinicalTrials.gov Identifier: | NCT01599559 |
| Other Study ID Numbers: |
IELSG37 |
| First Posted: | May 16, 2012 Key Record Dates |
| Last Update Posted: | October 19, 2023 |
| Last Verified: | October 2023 |
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previously untreated |
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Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |