RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have low-grade stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.
OBJECTIVES: * 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 regimens. 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 weeks. * 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 annually thereafter. PROJECTED ACCRUAL: A total of 344 patients will be accrued for this study within 6 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
204
U.Z. Gasthuisberg
Leuven, Belgium
Universitair Medisch Centrum St. Radboud - Nijmegen
Leuven, Belgium
University Hospital Rebro
Zagreb, Croatia
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark
National Cancer Institute of Egypt
Cairo, Egypt
Centre D'Oncologie Du Pays-Basque
Bayonne, France
Institut Bergonie
Bordeaux, France
Centre Hospitalier de Dax
Dax, France
Hopital Robert Boulin
Libourne, France
Polyclinique Francheville
Périgueux, France
...and 5 more locations
Disease-free survival
Overall survival
Quality of life as assessed by European Organization of Research for the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30
Response as assessed by Cheson criteria
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