Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT00028691|
Recruitment Status : Unknown
Verified January 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: chlorambucil Radiation: radiation therapy||Phase 3|
- Compare the effect of chlorambucil vs involved-field radiotherapy on progression-free survival of patients with previously untreated stage III or IV follicular lymphoma.
- Compare the complete and partial remission rates and overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral chlorambucil on days 1-5. Treatment repeats every 4 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo radiotherapy on days 1 and 3 (and days 15 and 17 for split course).
Quality of life is assessed at baseline, prior to course 3, 6, and 8 (arm I), and then at 4-6 weeks after study.
Patients are followed at 4-6 weeks, 3-4 months (arm I), 3 months and 6 months (arm II), 11, 12, 15, 18, and 21 months, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 444 patients (222 per treatment arm) will be accrued for this study within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial|
|Study Start Date :||December 2002|
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): NCT00028691
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1081HV|
|Akademisch Medisch Centrum|
|Amsterdam, Netherlands, 1105 AZ|
|Medisch Spectrum Twente|
|Enschede, Netherlands, 7500 KA|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9713 EZ|
|Heerlen, Netherlands, NL-6401 PC|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Radiotherapeutisch Instituut Limburg-Maastricht|
|Maastricht, Netherlands, NL-6229 ET|
|Daniel Den Hoed Cancer Center at Erasmus University Medical Center|
|Rotterdam, Netherlands, 3075 EA|
|OverallOfficial:||Rick L. M. Haas, MD||The Netherlands Cancer Institute|
|OverallOfficial:||T. Girinsky, MD||Gustave Roussy, Cancer Campus, Grand Paris|