Radiation Therapy vs Observation for B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+84 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: International Extranodal Lymphoma Study Group (IELSG)

No Placebo Group

Trial Summary

What is the purpose of this trial?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trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active.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.

Eligibility Criteria

Adults with newly diagnosed primary mediastinal large B-cell lymphoma, CD20 positive, without extranodal disease outside the chest. They must have completed chemoimmunotherapy without autologous stem cell support and show no active tumor on PET/CT. Excludes pregnant women, those with certain psychological or medical conditions, HIV-positive individuals, and recent history of other cancers.

Inclusion Criteria

I am considered healthy enough to undergo chemotherapy and radiotherapy aimed at curing my condition.

Able and willing to give informed consent, and to undergo staging including PET scanning

I am 18 years old or older.

+7 more

Exclusion Criteria

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.

+2 more

Participant Groups

This trial is testing if radiation therapy after chemoimmunotherapy is necessary for patients whose PET/CT scans don't show active tumors. Participants are randomly assigned to either receive radiation treatment or undergo careful observation to compare progression-free survival rates.

2Treatment groups

Experimental Treatment

Active Control

Group I: observationExperimental Treatment1 Intervention

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.

Group II: mediastinal irradiationActive Control1 Intervention

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.