Involved-Field Radiation Therapy in Treating Patients With Previously Untreated Stage I or Stage II Low-Grade Non-Hodgkin's Lymphoma
NCT ID: NCT00014326
Last Updated: 2012-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
204 participants
INTERVENTIONAL
2001-01-31
Brief Summary
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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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* 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
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Pierre Richaud, MD
Role: STUDY_CHAIR
Institut Bergonié
Marten Beijert, MD
Role: STUDY_CHAIR
University Medical Center Groningen, Groningen
Locations
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U.Z. Gasthuisberg
Leuven, , Belgium
Universitair Medisch Centrum St. Radboud - Nijmegen
Leuven, , Belgium
University Hospital Rebro
Zagreb, , Croatia
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
National Cancer Institute of Egypt
Cairo, , Egypt
Centre D'Oncologie Du Pays-Basque
Bayonne, , France
Institut Bergonie
Bordeaux, , France
Centre Hospitalier de Dax
Dax, , France
Hopital Robert Boulin
Libourne, , France
Polyclinique Francheville
Périgueux, , France
Medisch Spectrum Twente
Enschede, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Maastro Clinic - Locatie Maastricht
Maastricht, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Dr. Bernard Verbeeten Instituut
Tilburg, , Netherlands
Countries
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Other Identifiers
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EORTC-20971
Identifier Type: -
Identifier Source: secondary_id
EORTC-22997
Identifier Type: -
Identifier Source: secondary_id
EORTC-20971-22997
Identifier Type: -
Identifier Source: org_study_id