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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 (NCT00004031)

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
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.
  • Biological: rituximab
    375 mg/m2 IV every 21 days
    • Drug: CHOP regimen
      • Drug: carmustine
        • Drug: cyclophosphamide
          • Drug: doxorubicin hydrochloride
            • Drug: etoposide
              • Drug: prednisone
                • Drug: vincristine sulfate
                  • Procedure: bone marrow ablation with stem cell support
                    • Procedure: peripheral blood stem cell transplantation
                      • Radiation: radiation therapy
                        Ages eligible for Study
                        15 Years to 65 Years
                        Genders eligible for Study
                        Accepts Healthy Volunteers

                        - Compare the overall survival and progression-free survival of patients with intermediate- or high-grade non-Hodgkin's lymphoma treated with high-dose chemoradiotherapy and autologous peripheral blood stem cell transplantation (APBSCT) vs conventional dose cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (or CHOP plus rituximab for CD20+ disease) with possible late APBSCT.

                        - Compare the toxic effects of these regimens in this patient population.

                        OUTLINE: This is a randomized study. Patients are stratified according to disease risk (intermediate-high vs high).

                        Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients with CD20-positive disease also receive rituximab IV on day 1 (or day 0 during course 1 only). Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

                        Within 35 days of completing the fifth course, patients with partial or complete response are randomized to one of two treatment arms.

                        - Arm I: Patients receive CHOP (or CHOP plus rituximab [CHOP-R]) as above. Treatment repeats every 3 weeks for 3 additional courses. After completion of chemotherapy, patients are encouraged to undergo harvest of peripheral blood stem cells (PBSC) for possible use at time of relapse. After completion of 8 courses, patients receive no additional therapy until disease progression or biopsy-proven disease.

                        - Arm II: Patients receive one additional course of CHOP/CHOP-R followed by filgrastim (G-CSF), sargramostim (GM-CSF), or other colony-stimulating factors used singly or in combination according to center preference. PBSC are harvested and selected for CD34+ cells. Patients under age 61 receive one of two preparative regimens: a total body irradiation (TBI)-based regimen comprising irradiation administered twice daily on days -8 to -5, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2 OR carmustine IV over 2 hours on days -6 to -4 and etoposide and cyclophosphamide as in the TBI-based regimen. Patients age 61 to 65 receive the augmented regimen comprising carmustine, etoposide, and cyclophosphamide as above. Patients receive involved field radiotherapy prior to the preparative regimen only if there is biopsy-proven residual bulk disease and at the discretion of the center. PBSC are reinfused 36-48 hours after completion of cyclophosphamide. If both bone marrow and PBSC are harvested, bone marrow is reinfused on day 0 and then PBSC are reinfused either the same day or the following day.

                        Patients are followed every 6 months for 2 years and then annually thereafter.

                        PROJECTED ACCRUAL: Approximately 360 patients (at least 135 per treatment arm) will be accrued for this study within 5 years.

                        14 locations

                        Canada (14)
                        • Tom Baker Cancer Centre - Calgary
                          Not specified
                          Calgary, Alberta, Canada, T2N 4N2
                        • Cross Cancer Institute at University of Alberta
                          Not specified
                          Edmonton, Alberta, Canada, T6G 1Z2
                        • CancerCare Manitoba
                          Not specified
                          Winnipeg, Manitoba, Canada, R3E 0V9
                        • Moncton Hospital
                          Not specified
                          Moncton, New Brunswick, Canada, E1C 6Z8
                        • Doctor H. Bliss Murphy Cancer Centre
                          Not specified
                          St. John's, Newfoundland and Labrador, Canada, AIB 3V6
                        • Nova Scotia Cancer Centre
                          Not specified
                          Halifax, Nova Scotia, Canada, B3H 1V7
                        • Margaret and Charles Juravinski Cancer Centre
                          Not specified
                          Hamilton, Ontario, Canada, L8V 5C2
                        • London Regional Cancer Program at London Health Sciences Centre
                          Not specified
                          London, Ontario, Canada, N6A 4L6
                        • Odette Cancer Centre at Sunnybrook
                          Not specified
                          Toronto, Ontario, Canada, M4N 3M5
                        • Hopital Notre-Dame du CHUM
                          Not specified
                          Montreal, Quebec, Canada, H2L 4M1
                        • Hopital Du Sacre-Coeur de Montreal
                          Not specified
                          Montreal, Quebec, Canada, H4J 1C5
                        • Centre Hospitalier Universitaire de Quebec
                          Not specified
                          Quebec City, Quebec, Canada, G1R 2J6
                        • Hopital du Saint-Sacrement - Quebec
                          Not specified
                          Quebec City, Quebec, Canada, G1S 4L8
                        • Saskatoon Cancer Centre at the University of Saskatchewan
                          Not specified
                          Saskatoon, Saskatchewan, Canada, S7N 4H4
                        30 June, 1997
                        21 May, 2013
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