NCT00014326

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
RADIATION	radiation therapy

Timeline

• Start date: 2001-01-01
• Primary completion: 2009-03-01
• First posted: 2003-01-27
• Last updated: 2012-07-16

Locations

15 sites across 6 countries: Belgium, Croatia, Denmark, Egypt, France, Netherlands