Phase 3
N=253
SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00004031 ↗Enrolled (actual)
253
Serious AEs
3.4%
Results posted
Feb 2021
Primary outcome: Primary: 2-year Overall Survival Rates — 71.1; 73.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rituximab (Biological); CHOP regimen (Drug); carmustine (Drug); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisone (Drug); vincristine sulfate (Drug); bone marrow ablation with stem cell support (Procedure); peripheral blood stem cell transplantation (Procedure); radiation therapy (Radiation)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-year Overall Survival Rates |
71.1; 73.7 | — |
| PRIMARY 2 Year Progression-free Survival |
55.4; 69.1 | — |
| SECONDARY Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
8; 9; 9; 15; 0; 8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00004031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.