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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014326 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 344 |
| Study Start Date: | January 2001 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I or II, low-grade, non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Leuven, Belgium, B-3000 | |
| Croatia | |
| University Hospital Rebro | |
| Zagreb, Croatia, 41000 | |
| Denmark | |
| Rigshospitalet - Copenhagen University Hospital | |
| Copenhagen, Denmark, 2100 | |
| Egypt | |
| National Cancer Institute of Egypt | |
| Cairo, Egypt | |
| France | |
| Centre D'Oncologie Du Pays-Basque | |
| Bayonne, France, F-64100 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Hospitalier de Dax | |
| Dax, France, 40107 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Polyclinique Francheville | |
| Perigueux, France, 24004 | |
| Netherlands | |
| 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 | |
| Investigator: | Pierre Richaud, MD | Institut Bergonié |
More Information
| ClinicalTrials.gov Identifier: | NCT00014326 History of Changes |
| Other Study ID Numbers: | CDR0000068532, EORTC-20971, EORTC-22997 |
| Study First Received: | April 10, 2001 |
| Last Updated: | June 19, 2010 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |