NCT00005089

S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2000-04-01
• Primary completion: 2004-11-01
• Completion: 2014-04-01
• First posted: 2004-02-16
• Last updated: 2017-01-16

Locations

92 sites across 1 country: United States