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

September 16, 2013 updated by: Commissie Voor Klinisch Toegepast Onderzoek

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

Unknown

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

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • Algemeen Ziekenhuis Middelheim
  • France
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoek Hospital
      • Amsterdam, Netherlands, 1081HV
        • Vrije Universiteit Medisch Centrum
      • Amsterdam, Netherlands, 1105 AZ
        • Akademisch Medisch Centrum
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Heerlen, Netherlands, NL-6401 PC
        • Maastro Clinic
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center
      • Maastricht, Netherlands, NL-6229 ET
        • Radiotherapeutisch Instituut Limburg-Maastricht
      • Rotterdam, Netherlands, 3075 EA
        • Daniel Den Hoed Cancer Center at Erasmus University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Commissie Voor Klinisch Toegepast Onderzoek

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Rick L. M. Haas, MD, The Netherlands Cancer Institute
  • T. Girinsky, MD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

January 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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