Lymphoma Clinical Trial
Official title:
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.
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