Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial
- Compare the effect of chlorambucil vs involved-field radiotherapy on progression-free
survival of patients with previously untreated stage III or IV follicular lymphoma.
- Compare the complete and partial remission rates and overall survival of patients
treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral chlorambucil on days 1-5. Treatment repeats every 4 weeks
for 6-8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo radiotherapy on days 1 and 3 (and days 15 and 17 for split
Quality of life is assessed at baseline, prior to course 3, 6, and 8 (arm I), and then at
4-6 weeks after study.
Patients are followed at 4-6 weeks, 3-4 months (arm I), 3 months and 6 months (arm II), 11,
12, 15, 18, and 21 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 444 patients (222 per treatment arm) will be accrued for this
study within 4 years.
Allocation: Randomized, Primary Purpose: Treatment
Rick L. M. Haas, MD
The Netherlands Cancer Institute
United States: Federal Government