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Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
This study is ongoing, but not recruiting participants.
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028691

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
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Rick L. M. Haas, MD Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Investigator: T. Girinsky, MD Institut Gustave Roussy
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 09, 2009