Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma

Overview

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different regimens of low-dose radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.

OBJECTIVES: Primary * Compare the local progression-free interval in patients with follicular non-Hodgkin's lymphoma (NHL) treated with 2 different regimens of low-dose radiotherapy. Secondary * Compare acute toxicity at 4 weeks in patients treated with these regimens. * Compare late toxicity in patients treated with these regimens. * Compare tumor response at 12 weeks in patients treated with these regimens. * Compare overall survival in patients treated with these regimens. * Assess the health economics of these regimens in these patients. OUTLINE: This is a multicenter, randomized study. Patients are randomized to one of two treatment arms. * Arm I 4Gy: Patients undergo low-dose radiotherapy once daily on days 1 and 2. * Arm II 24Gy: Patients undergo low-dose radiotherapy once daily on days 1-5, 8-12, 15, and 16. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up for 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study.

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