Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma

Phase 3

• Conditions: Lymphoma

• Registration Number: NCT00028691
• Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek

Brief Summary

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.

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 Timeline

• Status Verified: 2002-01
• Study First Submitted: 2002-01-04
• Study Start: 2002-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

Radiotherapeutisch Instituut Limburg-Maastricht; 🇳🇱 Maastricht, Netherlands

Daniel Den Hoed Cancer Center at Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands

Akademisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Maastro Clinic; 🇳🇱 Heerlen, Netherlands