Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lymphoma

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage I or II, low-grade, non-Hodgkin's lymphoma Follicular lymphoma grade I, II, or III Small lymphocytic lymphoma Lymphoplasmacytoid lymphoma Nodal marginal zone lymphoma Previously untreated disease At least 1 measurable or evaluable mass at least 1.1 cm (except for patients with stage I disease where the entire mass was removed for diagnostic purposes) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of indolent or aggressive lymphoma will replace the former terminology of low, intermediate, or high grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 2,000/mm ^3 Platelet count greater than 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No psychological, familial, sociological, or geographical condition that would preclude study participation Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No other concurrent anticancer therapy

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 |
| --- |
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, contiguous stage II small lymphocytic lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, nodal marginal zone B-cell lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma