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

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

A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma

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.

stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, Marginal zone lymphoma

DISEASE CHARACTERISTICS: Histologically confirmed follicular or mmarginal zone non-Hodgkin's lymphoma (NHL) Any stage Radiotherapy is indicated for curative treatment of stage IA or IIA disease OR palliation due to tumor bulk or anatomical position PATIENT CHARACTERISTICS: Life expectancy > 3 months PRIOR CONCURRENT THERAPY: More than 4 weeks since prior chemotherapy

Hoskin P, Popova B, Schofield O, Brammer C, Robinson M, Brunt AM, Madhavan K, Illidge T, Gallop-Evans E, Syndikus I, Clifton-Hadley L, Kirkwood AA. 4 Gy versus 24 Gy radiotherapy for follicular and marginal zone lymphoma (FoRT): long-term follow-up of a multicentre, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2021 Mar;22(3):332-340. doi: 10.1016/S1470-2045(20)30686-0. Epub 2021 Feb 1.

Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.