Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial
18 Years
N/A
Both
Lymphoma
Trial Information
Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Rick L. M. Haas, MD
Investigator Affiliation:
The Netherlands Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000069120
NCT ID:
NCT00028691
Start Date:
December 2002
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Follicular
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