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
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | October 2012 |
| End Date: | May 2025 |
| Contact: | Emanuele Zucca, MD |
| Email: | ielsg@eoc.ch |
| Phone: | ++41 91 811 90 40 |
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)
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necessary in patients where PET/CT has shown that the tumor is no longer active.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.
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.
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.
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