Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00014326|
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : July 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Official Title:||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|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||March 2009|
- Disease-free survival
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014326
|Leuven, Belgium, B-3000|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Leuven, Belgium, B-3000|
|University Hospital Rebro|
|Zagreb, Croatia, 41000|
|Rigshospitalet - Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|National Cancer Institute of Egypt|
|Centre D'Oncologie Du Pays-Basque|
|Bayonne, France, F-64100|
|Bordeaux, France, 33076|
|Centre Hospitalier de Dax|
|Dax, France, 40107|
|Hopital Robert Boulin|
|Libourne, France, 33500|
|Perigueux, France, 24004|
|Medisch Spectrum Twente|
|Enschede, Netherlands, 7500 KA|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|Maastro Clinic - Locatie Maastricht|
|Maastricht, Netherlands, NL-6229 ET|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Dr. Bernard Verbeeten Instituut|
|Tilburg, Netherlands, 5042 SB|
|Study Chair:||Pierre Richaud, MD||Institut Bergonié|
|Study Chair:||Marten Beijert, MD||University Medical Center Groningen, Groningen|