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

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

• Registration Number: NCT00005089
• Lead Sponsor: SWOG Cancer Research Network

Brief 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.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-04-06
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Primary Completion: 2004-11
• Study Completion: 2014-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHOP + Rituximab + RT	rituximab	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.
CHOP + Rituximab + RT	cyclophosphamide	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.
CHOP + Rituximab + RT	doxorubicin hydrochloride	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.
CHOP + Rituximab + RT	prednisone	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.
CHOP + Rituximab + RT	vincristine sulfate	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.
CHOP + Rituximab + RT	radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	every 6 weeks while on protocol treatment, then every 6 months for 2 years, then annually thereafter

Trial Locations

Locations (92)

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Hayden); 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan); 🇺🇸 Little Rock, Arkansas, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

Veterans Affairs Medical Center - Long Beach; 🇺🇸 Long Beach, California, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

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