A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized, Stages I and II, Low Grade Non-Hodgkin's Lymphoma
- Determine if the addition of low-dose total body irradiation (TBI) to involved-field
radiotherapy improves the disease-free survival of patients with previously untreated,
stage I or II low-grade non-Hodgkin's lymphoma.
- Determine the response of patients treated with low-dose TBI.
- Compare the overall survival and quality of life of patients treated with these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, stage (I vs II), performance status (0-1 vs 2), lactate dehydrogenase
elevation (yes vs no), histological subtype (small lymphocytic lymphoma vs
lymphoplasmacytoid lymphoma vs follicular lymphoma), and, for stage I patients, presence of
measurable mass (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo involved-field radiotherapy daily five days a week for 2.5-4
- Arm II: Patients undergo low-dose total body irradiation (TBI) daily 5 days a week on
weeks 1 and 4. At 4 weeks after completion of TBI, patients undergo involved-field
radiotherapy as in arm I.
Quality of life is assessed before treatment, at 4 weeks after completion of involved-field
radiotherapy, every 6 months for 5 years, and then annually thereafter.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 344 patients will be accrued for this study within 6 years.
Allocation: Randomized, Primary Purpose: Treatment
Pierre Richaud, MD
United States: Federal Government