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

This study is no longer recruiting patients.

Sponsors and Collaborators: Commissie Voor Klinisch Toegepast Onderzoek
EORTC Lymphoma Cooperative Group
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
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
 Drug: chlorambucil
 Procedure: chemotherapy
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Chlorambucil Versus Involved-Field Radiotherapy in Patients With Previously Untreated Stage III or IV Follicular Lymphoma

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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:

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:

Surgery:

  • Not specified

Location Information


Belgium
      Algemeen Ziekenhuis Middelheim, Antwerp,  2020,  Belgium

France
      Institut Gustave Roussy, Villejuif,  F-94805,  France

Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9713 EZ,  Netherlands

      Akademisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands

      Antoni van Leeuwenhoek Hospital, Amsterdam,  1066 CX,  Netherlands

      Daniel Den Hoed Cancer Center at Erasmus University Medical Center, Rotterdam,  3075 EA,  Netherlands

      Leiden University Medical Center, Leiden,  2300 RC,  Netherlands

      Maastro Clinic, HEERLEN,  NL-6401 PC,  Netherlands

      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands

      Radiotherapeutisch Instituut Limburg-Maastricht, Maastricht,  NL-6229 ET,  Netherlands

      Vrije Universiteit Medisch Centrum, Amsterdam,  1081HV,  Netherlands

Study chairs or principal investigators

Rick L. M. Haas, MD,  Antoni van Leeuwenhoek Hospital   
T. Girinsky, MD,  Institut Gustave Roussy   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069120; CKVO-2001-01; HOVON-47NHL; EU-20131; HOVON-CKTO-2001-01; EORTC-20013
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028691
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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