![]() Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I.Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ![]() ![]() Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I.Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5.Patients with non-bulky disease are randomized to treatment arms I or III.Īll patients will be given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0. Patients with initial bulky disease and/or qualifying extranodal involvement are randomized to 1 of 4 treatment arms. Patients are stratified according to study center, serum lactic dehydrogenase level (≤ upper limit of normal vs > ULN), disease stage (I or II vs III or IV), ECOG performance status (0-1 vs 2-3), bulky disease, and extranodal involvement. OUTLINE: This is an open-label, randomized, multicenter study. Compare patient adherence to these regimens.Compare the pharmacoeconomics of these regimens.Compare the safety of these regimens in these patients.Compare the tumor control in patients treated with these regimens.Compare the complete response rate in patients treated with these regimens.Compare the overall and disease-free/relapse-free survival of patients treated with these regimens.Compare the time to progression in patients treated with these regimens.Compare the time to treatment failure in patients with previously untreated, low-risk, aggressive, B-cell non-Hodgkin's lymphoma treated with 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone with vs without radiotherapy.Condition or diseaseīiological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Others interfere with the ability of cancer cells to grow and spread. Some find cancer cells and kill them or carry cancer-killing substances to them. RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Why Should I Register and Submit Results?.
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