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



Status:Active, not recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2000
End Date:January 2017

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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

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.

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.

DISEASE CHARACTERISTICS: Histologically confirmed stage I, IE, or non-bulky II or IIE
non-Hodgkin's lymphoma of one of the following subtypes: Diffuse large B-cell Mantle cell
High grade B-cell, Burkitt's or Burkitt like Anaplastic large cell (B-cell phenotype only)
Lymphoma must express CD20 All disease must be encompassable in a single radiation port
(including any resected disease) Must have at least 1 of the following adverse prognostic
features: Non-bulky stage II or non-bulky stage IIE disease Over 60 years of age Zubrod
performance status of 2 Elevated serum LDH A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other:
No medical contraindications to CHOP chemotherapy or rituximab No prior malignancy within
past 5 years except adequately treated basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix No AIDS or HIV Not pregnant or nursing Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy
Chemotherapy: No prior chemotherapy for lymphoma Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified
We found this trial at
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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2010 E 90th St
Cleveland, Ohio 44195
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
(864) 404-2045
CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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Albuquerque, New Mexico 87108
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Albuquerque, New Mexico 87131
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Ann Arbor, Michigan 48106
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Atlanta, Georgia 30342
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Billings, Montana 59101
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Biloxi, Mississippi 39531
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Boston, Massachusetts 02118
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Cincinnati, Ohio 45220
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
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Dallas, Texas 75235
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Decatur, Illinois 62526
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2799 W Grand Blvd
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400 E Third Street
Duluth, Minnesota 55805
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Fort Gordon, Georgia 30905
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Kansas City, Missouri 64128
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Keesler AFB, Mississippi 39534
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Kettering, Ohio 45429
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
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400 30th Street, Suite 301
Oakland, California 94609
(510) 465-8016
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Oklahoma City, Oklahoma 73104
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Orange, California 92868
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Phoenix, Arizona 85006
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Portland, Oregon 97201
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Portland, Oregon 97225
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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3437 Caroline Mall
Saint Louis, Missouri 63110
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Saint Louis, Missouri 63141
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Salt Lake City, Utah 84112
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500 Foothill Drive
Salt Lake City, Utah 84148
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
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Tacoma, Washington 98405
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
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Temple, Texas 76508
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Travis Air Force Base, California 94535
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Wichita, Kansas 67214
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Winston-Salem, North Carolina 27104
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