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trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
540
observation
Radiation treatment should start within 6-8 weeks after the end of chemotherapy.
Norton Cancer Institute
Louisville, Kentucky, United States
Mayo Clinil Rocheser
Rochester, Minnesota, United States
MD Anderson Cancer Center
Houston, Texas, United States
Centro de Hematologia y Oncologia Pavlovsky
Buenos Aires, Argentina
Princess Margaret Hospital
Toronto, Canada
Ruijin Hospital
Progression free survival (PFS)
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.
Time frame: 30 months from the randomization
Overall survival (OS)
OS is defined as the time from registration until death as a result of any cause until five years from registration
Time frame: 5 years from registration
Long term toxicity
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)
Time frame: 10 years from registration
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Shanghai, China
Faculty Hospital Brno
Brno, Czechia
University Hospital
Hradec Králové, Czechia
Faculty Hospital Kralovske Vinohrady
Prague, Czechia
General University Hospital
Prague, Czechia
...and 75 more locations