Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00014326
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 204
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (15)
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
University Hospital Rebro
ðŸ‡ðŸ‡·Zagreb, Croatia
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Hopital Robert Boulin
🇫🇷Libourne, France
Centre D'Oncologie Du Pays-Basque
🇫🇷Bayonne, France
Polyclinique Francheville
🇫🇷Perigueux, France
Rigshospitalet - Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Maastro Clinic - Locatie Maastricht
🇳🇱Maastricht, Netherlands
Institut Bergonie
🇫🇷Bordeaux, France
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇧🇪Leuven, Belgium
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Centre Hospitalier de Dax
🇫🇷Dax, France