SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2013-10-31
• 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation and kill more cancer cells. It is not yet known whether chemoradiotherapy plus peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying chemoradiotherapy and peripheral stem cell transplantation to see how well they work compared to combination chemotherapy in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI); NCIC Clinical Trials Group
• Treatments: Carmustine; Cyclophosphamide; Doxorubicin; Etoposide; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven intermediate- or high-grade non-Hodgkin's lymphoma

• Ann Arbor classification of "bulky" stage II, III, or IV

• Must be classified as high-intermediate or high-risk according to International Age Adjusted Index

• Bidimensionally measurable disease

• No lymphoblastic, transformed, or mantle cell lymphomas

• No CNS involvement by lymphoma

• CD20 status confirmed by immunocytochemistry or flow cytometry

• Must have either bilateral or unilateral bone marrow aspiration and biopsy ≥ 42 days before first course of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy (or CHOP plus rituximab [CHOP-R] for CD20+ disease) OR within 42 days prior to registration if CHOP/CHOP-R therapy has not begun

• Must have bilateral bone marrow aspiration and biopsy within 28 days of randomization

• Bone marrow involvement with lymphoma is allowed, provided there is an improvement of at least 50% if used as an evaluable site of disease

• No prior lymphoma, Hodgkin's lymphoma, myelodysplastic syndromes, or leukemia NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 15 to 65

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• No nonlymphoma-related hepatic dysfunction

Renal:

• Creatinine no greater than 2 times ULN

• Creatinine clearance at least 60 mL/min

• No nonlymphoma-related renal dysfunction

• No history of grade 3 hemorrhagic cystitis due to cyclophosphamide

Cardiovascular:

• No coronary artery disease, cardiomyopathy, congestive heart failure, or dysrhythmia requiring therapy

• MUGA scan or 2-D echocardiogram required if patient's history is questionable

• Ejection fraction normal

Pulmonary:

• DLCO or FEV_1 at least 60% of predicted

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No allergy to etoposide

• No active bacterial, fungal, or viral infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior monoclonal antibody therapy for lymphoma except if included in a single course of CHOP/CHOP-R

Chemotherapy:

• No prior chemotherapy for lymphoma except for a single course of CHOP/CHOP-R* NOTE:

*Prednisone or other corticosteroids not considered prior chemotherapy

Endocrine therapy:

• See Chemotherapy

• Prior corticosteroids allowed

Radiotherapy:

• No prior radiotherapy for lymphoma

• No prior thoracic radiotherapy or radiotherapy greater than 2,000 cGy to any other site

Surgery:

• Not specified