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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek
• Collaborator: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: 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