|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Commissie Voor Klinisch Toegepast Onderzoek |
|---|---|
| Collaborator: |
European Organization for Research and Treatment of Cancer |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028691 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: chlorambucil Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of follicular lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| Belgium | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| France | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Netherlands | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9713 EZ | |
| Akademisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1081HV | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Maastro Clinic | |
| Heerlen, Netherlands, NL-6401 PC | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands, 7500 KA | |
| Radiotherapeutisch Instituut Limburg-Maastricht | |
| Maastricht, Netherlands, NL-6229 ET | |
| Daniel Den Hoed Cancer Center at Erasmus University Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| Investigator: | Rick L. M. Haas, MD | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
| Investigator: | T. Girinsky, MD | Institut Gustave Roussy |
More Information
| Study ID Numbers: | CDR0000069120, CKVO-2001-01, HOVON-47NHL, EU-20131, HOVON-CKTO-2001-01, EORTC-20013 |
| Study First Received: | January 4, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028691 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma |
stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Chlorambucil Lymphoma, Follicular Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Alkylating Agents |