S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: rituximabRadiation: 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Not provided
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, 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
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Center
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States