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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
chlorambucil
radiation therapy
Sponsored by
Commissie Voor Klinisch Toegepast Onderzoek
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • Institut Gustave Roussy
  • Antoni van Leeuwenhoek Hospital
  • Vrije Universiteit Medisch Centrum
  • Akademisch Medisch Centrum
  • Medisch Spectrum Twente
  • Academisch Ziekenhuis Groningen
  • Maastro Clinic
  • Leiden University Medical Center
  • Radiotherapeutisch Instituut Limburg-Maastricht
  • Daniel Den Hoed Cancer Center at Erasmus University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
September 16, 2013
Sponsor
Commissie Voor Klinisch Toegepast Onderzoek
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00028691
Brief Title
Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Unknown status
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Commissie Voor Klinisch Toegepast Onderzoek
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chlorambucil
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick L. M. Haas, MD
Organizational Affiliation
The Netherlands Cancer Institute
First Name & Middle Initial & Last Name & Degree
T. Girinsky, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Akademisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Groningen
City
Groningen
ZIP/Postal Code
9713 EZ
Country
Netherlands
Facility Name
Maastro Clinic
City
Heerlen
ZIP/Postal Code
NL-6401 PC
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut Limburg-Maastricht
City
Maastricht
ZIP/Postal Code
NL-6229 ET
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
12756499
Citation
Haas RL, Girinsky T. HOVON 47/EORTC 20013: chlorambucil vs 2x2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. Ann Hematol. 2003 Jul;82(7):458-62. doi: 10.1007/s00277-003-0655-8. Epub 2003 May 20. No abstract available.
Results Reference
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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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