Clinical trial · Interventional
SWOG-9704 Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups
NCT00004031CI-TRIAL-00049794completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| CHOP regimen | Drug | CHOP Regimen | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CHOP/CHOP-R x 3
- description
- Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 8 cycles
- interventionNames
- Biological: rituximab
- Drug: CHOP regimen
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisone
- Drug: vincristine sulfate
- Procedure: bone marrow ablation with stem cell support
- type
- EXPERIMENTAL
- label
- CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant
- description
- Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Prednisone 100 mg/day PO Days 1-5 Vincristine 1.4 mg/m2 IV Day 1 Rituximab 375 mg/m2 IV Day 1 This regimen is repeated every 21 days for 6 cycles followed by autologous stem cell transplant.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTStiff PJ, Unger JM, Cook J, et al.: Randomized phase III U.S./Canadian intergroup trial (SWOG S9704) comparing CHOP ± R for eight cycles to CHOP ± R for six cycles followed by autotransplant for patients with high-intermediate (H-Int) or high IPI grade diffuse aggressive non-Hodgkin lymphoma (NHL). [Abstract] J Clin Oncol 29 (Suppl 15): A-8001, 2011.
- DERIVEDCook JR, Goldman B, Tubbs RR, Rimsza L, Leblanc M, Stiff P, Fisher R. Clinical significance of MYC expression and/or "high-grade" morphology in non-Burkitt, diffuse aggressive B-cell lymphomas: a SWOG S9704 correlative study. Am J Surg Pathol. 2014 Apr;38(4):494-501. doi: 10.1097/PAS.0000000000000147. PMID 24625415
- DERIVEDStiff PJ, Unger JM, Cook JR, Constine LS, Couban S, Stewart DA, Shea TC, Porcu P, Winter JN, Kahl BS, Miller TP, Tubbs RR, Marcellus D, Friedberg JW, Barton KP, Mills GM, LeBlanc M, Rimsza LM, Forman SJ, Fisher RI. Autologous transplantation as consolidation for aggressive non-Hodgkin's lymphoma. N Engl J Med. 2013 Oct 31;369(18):1681-90. doi: 10.1056/NEJMoa1301077. PMID 24171516