Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: chlorambucil
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of follicular lymphoma Stage III or IV disease Grades I, II, or III Previously untreated disease Nodal and extranodal sites Bidimensionally measurable disease by physical examination or diagnostic imaging No CNS or orbital non-Hodgkin's lymphoma localization PATIENT CHARACTERISTICS: Age: 18 and over (for patients at EORTC centers) 65 and over (for patients at HOVON centers) Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 6.0 g/dL Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease that would preclude study treatment Pulmonary: No severe pulmonary disease that would preclude study treatment Other: HIV negative No severe neurologic, psychiatric, or metabolic disease that would preclude study treatment No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent systemic corticosteroids, including dexamethasone for nausea and vomiting palliation (inhalation and topical corticosteroids allowed) Radiotherapy: No concurrent elective radiotherapy to an adjacent negative lymph node Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlorambucil|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma