S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma|
- Progression-free survival [ Time Frame: every 6 weeks while on protocol treatment, then every 6 months for 2 years, then annually thereafter ] [ Designated as safety issue: No ]
|Study Start Date:||April 2000|
|Study Completion Date:||April 2014|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Experimental: CHOP + Rituximab + RT
3 21-day cycles of CHOP (cyclophosphamide 750 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2, prednisone 100 mg x 5 days) + Rituximab 375 mg/m^2 (x 2 days for cycle 1, x 3 days for cycles 2-3). RT 4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
375 mg/m^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.Drug: cyclophosphamide
750 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.Drug: doxorubicin hydrochloride
50 mg/m^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.Drug: prednisone
100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.Drug: vincristine sulfate
1.4 mg/m^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.Radiation: radiation therapy
4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
OBJECTIVES: I. Assess two year progression free survival after treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab followed by radiotherapy in patients with stage I, IE, or non-bulky stage II or IIE high risk localized intermediate or high grade non-Hodgkin's lymphoma. II. Determine the toxicity of this treatment in these patients.
OUTLINE: Patients receive rituximab IV on days 1 and 8 of the first course, then on day 1 of courses 2 and 3. Patients receive cyclophosphamide IV over 1-2 hours, doxorubicin IV, and vincristine IV on day 10 of the first course, then on day 3 of courses 2 and 3. Patients receive oral prednisone on days 10-14 of the first course, then on days 3-7 of courses 2 and 3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Chemotherapy is followed by radiotherapy administered 5 days a week for 4-5 weeks. Patients are followed every 6 months for two years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005089
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|Study Chair:||Thomas P. Miller, MD||University of Arizona|