Lymphoma Clinical Trial
Official title:
Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
cells. It is not yet known if chlorambucil is more effective than radiation therapy in
treating follicular lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that
of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma
that has not been previously treated.
OBJECTIVES:
- 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
course).
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
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