- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028691
Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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
Phase
- Phase 3
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2020
- Algemeen Ziekenhuis Middelheim
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Amsterdam, Netherlands, 1066 CX
- Antoni van Leeuwenhoek Hospital
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Amsterdam, Netherlands, 1081HV
- Vrije Universiteit Medisch Centrum
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Amsterdam, Netherlands, 1105 AZ
- Akademisch Medisch Centrum
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Enschede, Netherlands, 7500 KA
- Medisch Spectrum Twente
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Groningen, Netherlands, 9713 EZ
- Academisch Ziekenhuis Groningen
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Heerlen, Netherlands, NL-6401 PC
- Maastro Clinic
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Leiden, Netherlands, 2300 RC
- Leiden University Medical Center
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Maastricht, Netherlands, NL-6229 ET
- Radiotherapeutisch Instituut Limburg-Maastricht
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Rotterdam, Netherlands, 3075 EA
- Daniel Den Hoed Cancer Center at Erasmus University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of follicular lymphoma
- Stage III or IV disease
- Grades I, II, or III
- Previously untreated disease
- Nodal and extranodal sites
- Bidimensionally measurable disease by physical examination or diagnostic imaging
- No CNS or orbital non-Hodgkin's lymphoma localization
PATIENT CHARACTERISTICS:
Age:
- 18 and over (for patients at EORTC centers)
- 65 and over (for patients at HOVON centers)
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 6.0 g/dL
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No severe cardiac disease that would preclude study treatment
Pulmonary:
- No severe pulmonary disease that would preclude study treatment
Other:
- HIV negative
- No severe neurologic, psychiatric, or metabolic disease that would preclude study treatment
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent systemic corticosteroids, including dexamethasone for nausea and vomiting palliation (inhalation and topical corticosteroids allowed)
Radiotherapy:
- No concurrent elective radiotherapy to an adjacent negative lymph node
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Rick L. M. Haas, MD, The Netherlands Cancer Institute
- T. Girinsky, MD, Gustave Roussy, Cancer Campus, Grand Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Chlorambucil
Other Study ID Numbers
- CDR0000069120
- CKVO-2001-01
- HOVON-47NHL
- EU-20131
- HOVON-CKTO-2001-01
- EORTC-20013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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