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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.

Sponsors and Collaborators: Commissie Voor Klinisch Toegepast Onderzoek
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
Procedure: radiation therapy
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Chlorambucil   

U.S. FDA Resources

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

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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000069120, CKVO-2001-01, HOVON-47NHL, EU-20131, HOVON-CKTO-2001-01, EORTC-20013
First Received:   January 4, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00028691
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

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Chlorambucil
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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