Overview
Chlorambucil Compared With Radiation Therapy in Treating Patients With Previously Untreated Stage III or Stage IV Follicular Lymphoma
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Commissie Voor Klinisch Toegepast OnderzoekCollaborator:
European Organisation for Research and Treatment of Cancer - EORTCTreatments:
Chlorambucil
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