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

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ClinicalTrials.gov Identifier: NCT00028691
Recruitment Status : Unknown
Verified January 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: chlorambucil Radiation: radiation therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028691


Locations
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Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
France
Institut Gustave Roussy
Villejuif, France, F-94805
Netherlands
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081HV
Akademisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Maastro Clinic
Heerlen, Netherlands, NL-6401 PC
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
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 Organisation for Research and Treatment of Cancer - EORTC
Investigators
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OverallOfficial: Rick L. M. Haas, MD The Netherlands Cancer Institute
OverallOfficial: T. Girinsky, MD Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00028691    
Other Study ID Numbers: CDR0000069120
CKVO-2001-01
HOVON-47NHL
EU-20131
HOVON-CKTO-2001-01
EORTC-20013
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: January 2002
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:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Chlorambucil
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents