IELSG 37
Research type
Research Study
Full title
A randomized, open label, multicentre, two-arm phase III comparative study assessing the role of mediastinal radiotherapy after rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)
IRAS ID
122841
Contact name
Kelly Cozens
Contact email
Sponsor organisation
International Extranodal Lymphoma Study Group (IELSG)
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Primary mediastinal Large B-cell lymphoma (PMBL), accounts for less than 5% of non-Hodgkin’s lymphoma's (NHL) occurring predominantly in females with a median age at presentation in the third or fourth decades. It is estimated that of the 12,000 newly diagnosed NHL cases per annum, 500 will be PMBL. Current practice is to give intensive chemotherapy sometimes with the addition of mediastinal radiotherapy (RT). Uncertainty exists however, as to whether consolidation radiotherapy following immunochemotherapy is necessary and given the late effects of such treatment whether PET scanning can be used to discriminate between patients who require radiation from those who do not. Functional imaging with PET scanning has been shown to distinguish between residual masses which contain active lymphoma and those where the lymphoma has been eliminated. Although used to determine treatment options in many other lymphomas, whether it can be used similarly in PMBL has yet to be determined.
This trial aims to answer this question by recruiting 752 newly diagnosed patients with PMBL who are due to receive a standard chemotherapy regimen which contains rituximab. Patients will be recruited from 21 countries internationally (including 14 sites in the UK). Patients will receive an initial PET/CT scan before they commence their chemotherapy. Following chemotherapy they will receive a further PET/CT scan. Patients whose PET scans are negative will be randomised to receive either consolidation radiotherapy or observation. Patients with a positive PET or who achieve a partial response will not be randomised but referred back to their clinician for further treatment. The primary endpoint is progression free survival at two years. Randomised patients will be followed up for 10 years to assess overall survival and safety. Those not randomised will be followed up to ascertain their response to the treatment given by the investigator, disease progression and overall survival.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0317
Date of REC Opinion
9 Sep 2013
REC opinion
Further Information Favourable Opinion