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Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

Primary Purpose

Anal Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

cisplatin

fluorouracil

mitomycin C

radiation therapy

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring stage II anal cancer, stage III anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, other than carcinoma in situ T2-4, Any N, M0 (stage II or III) No local or regional recurrence after local excision or abdominal peritoneal resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Absolute neutrophil count at least 1,800/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.4 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 80 mL/min Cardiovascular: No uncompensated heart disease No uncontrolled high blood pressure Other: No AIDS No active systemic infection No uncontrolled diabetes No other prior malignancy within the past 5 years except nonmelanoma skin cancer No mental condition that would preclude study participation Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior epoetin alfa allowed in lieu of blood transfusions Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 5 years since prior radiotherapy Surgery: No prior surgery of anal canal except for biopsy of study site

Sites / Locations

Comprehensive Cancer Center at University of Alabama at Birmingham
Mobile Infirmary Medical Center
Alaska Regional Hospital
Providence Alaska Medical Center
Foundation for Cancer Research and Education
CCOP - Mayo Clinic Scottsdale Oncology Program
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Alta Bates Comprehensive Cancer Center
Providence Saint Joseph Medical Center - Burbank
Mills-Peninsula Health Services
Mount Diablo Regional Cancer Center
City of Hope Comprehensive Cancer Center
California Cancer Center - Woodward Park Office
Marin Cancer Institute at Marin General Hospital
Sutter Health Western Division Cancer Research Group
Saint Rose Hospital
Valley Memorial Hospital
Loma Linda University Cancer Institute at Loma Linda University Medical Center
USC/Norris Comprehensive Cancer Center and Hospital
Providence Holy Cross Cancer Center
Memorial Medical Center Cancer Services
Leavey Cancer Center at Northridge Hospital Medical Center
Highland General Hospital
CCOP - Bay Area Tumor Institute
Summit Medical Center
Palo Alto Medical Foundation
Pomona Valley Hospital Medical Center
Radiological Associates of Sacramento Medical Group, Inc.
University of California Davis Cancer Center
Naval Medical Center - San Diego
California Pacific Medical Center - California Campus
J.C. Robinson, M.D. Regional Cancer Center
CCOP - Santa Rosa Memorial Hospital
Torrance Memorial Medical Center
Sutter Solano Medical Center
Aurora Presbyterian Hospital
Boulder Community Hospital
Memorial Hospital Cancer Center
Penrose Cancer Center at Penrose Hospital
Porter Adventist Hospital
Presbyterian - St. Luke's Medical Center
St. Joseph Hospital
Rose Medical Center
CCOP - Colorado Cancer Research Program, Incorporated
Swedish Medical Center
Front Range Cancer Specialists
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Sky Ridge Medical Center
Hope Cancer Care Center at Longmont United Hospital
St. Mary-Corwin Regional Medical Center
North Suburban Medical Center
Middlesex Hospital Cancer Center
Beebe Medical Center
CCOP - Christiana Care Health Services
St. Francis Hospital
Lombardi Cancer Center at Georgetown University Medical Center
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
21st Century Oncology - Fort Myers
Memorial Cancer Institute at Memorial Regional Hospital
Baptist Cancer Institute - Jacksonville
Mayo Clinic - Jacksonville
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
CCOP - Mount Sinai Medical Center
University of Miami Sylvester Comprehensive Cancer Center
Baptist-South Miami Regional Cancer Program
Gulf Coast Cancer Treatment Center
Tallahassee Memorial Hospital
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Emory University Hospital - Atlanta
Northeast Georgia Medical Center
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Mountain States Tumor Institute - Boise
Saint Anthony's Hospital at Saint Anthony's Health Center
Northwest Community Hospital
Rush-Copley Cancer Care Center
Good Shepherd Hospital
St. Joseph Medical Center
Graham Hospital
Memorial Hospital
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Cancer Care Center at Advocate Good Samaritan Hospital
St. Anthony's Memorial Hospital
Eureka Hospital
Evanston Northwestern Health Care - Evanston Hospital
Galesburg Clinic
Galesburg Cottage Hospital
InterCommunity Cancer Center of Western Illinois
Mason District Hospital
Hinsdale Hematology Oncology Associates
Hopedale Medical Complex
Joliet Oncology Hematology Associates, Limited - West
Kewanee Hospital
McDonough District Hospital
Edward Hospital Cancer Center
BroMenn Regional Medical Center
Community Cancer Center
Community Hospital of Ottawa
Oncology Hematology Associates of Central Illinois - Ottawa
Lutheran General Cancer Care Center
Cancer Treatment Center at Pekin Hospital
Methodist Medical Center of Illinois
Proctor Hospital
CCOP - Illinois Oncology Research Association
Oncology/Hematology Associates of Central Illinois, P.C.
OSF St. Francis Medical Center
Illinois Valley Community Hospital
Perry Memorial Hospital
Swedish American Hospital
St. Margaret's Hospital
Valley Cancer Center
Carle Cancer Center at Carle Foundation Hospital
CCOP - Carle Cancer Center
St. Francis Hospital and Health Centers
Bloomington Hospital
Elkhart General Hospital
Center for Cancer Therapy at LaPorte Hospital and Health Services
Saint Anthony Memorial Health Centers
Cancer Center at Ball Memorial Hospital
Saint Joseph Regional Medical Center - Plymouth Campus
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
Union Hospital
McFarland Clinic, P.C.
Saint Anthony Regional Hospital
St. Luke's Hospital
Cedar Rapids Oncology Associates
Mercy Cancer Center at Mercy Medical Center
Alegent Health Mercy Hospital
Genesis Regional Cancer Center at Genesis Medical Center
Genesis Medical Center - West Campus
Mercy Capitol Hospital
CCOP - Iowa Oncology Research Association
John Stoddard Cancer Center at Iowa Methodist Medical Center
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Medical Oncology and Hematology Associates at Mercy Cancer Center
Mercy Cancer Center at Mercy Medical Center - Des Moines
John Stoddard Cancer Center at Iowa Lutheran Hospital
Wendt Regional Cancer Center at Finley Hospital
Holden Comprehensive Cancer Center at University of Iowa
Mercy Cancer Center at Mercy Medical Center - North Iowa
Alegent Health Community Memorial Hospital
Burgess Health Center
Siouxland Hematology-Oncology Associates
Mercy Medical Center - Sioux City
St. Luke's Regional Medical Center
Medical Oncology and Hematology Associates - West Des Moines
South Central Kansas Regional Medical Center
Cancer Center of Kansas - Chanute
Cancer Center of Kansas - Dodge City
Cancer Center of Kansas, P.A. - El Dorado
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Cancer Center of Kansas - Kingman
Southwest Medical Center
Cancer Center of Kansas - Newton
Cancer Center of Kansas - Ottawa
Cancer Center of Kansas, P.A. - Parsons
Pratt Cancer Center of Kansas
Cancer Center of Kansas - Salina
Cancer Center of Kansas - Wellington
Associates in Womens Health
Cancer Center of Kansas, P.A.
Cancer Center of Kansas, P.A. - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Wesley Medical Center
Cancer Center of Kansas - Winfield
Cancer Treatment Center at the Medical Center - Bowling Green
Central Baptist Hospital
Markey Cancer Center at University of Kentucky Chandler Medical Center
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Louisiana State University Health Sciences Center - Monroe
Tulane Cancer Center
Veterans Affairs Medical Center - Shreveport
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
CancerCare of Maine at Eastern Maine Medial Center
Central Maine Medical Center
Maine General Medical Center - Waterville
DeCesaris Cancer Institute at Anne Arundel Medical Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Union Hospital Cancer Center at Union Hospital
Massachusetts General Hospital Cancer Center
Brigham and Women's Hospital
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Cancer Research Center at Boston Medical Center
Bethke Cancer Center at Emerson Hospital
Hudner Oncology Center at Saint Anne's Hospital
Cape Cod Hospital
Newton - Wellesley Hospital
South Suburban Oncology Center
Hickman Cancer Center at Bixby Medical Center
CCOP - Michigan Cancer Research Consortium
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
University of Michigan Comprehensive Cancer Center
Battle Creek Health System
Mecosta County General Hospital
Josephine Ford Cancer Center at Henry Ford Health System
Hurley Medical Center
Genesys Hurley Cancer Institute
Great Lakes Cancer Institute at McLaren Regional Medical Center
CCOP - Grand Rapids
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Spectrum Health Cancer Care - Butterworth Campus
Metropolitan Hospital
Spectrum Health Hospital - Blodgett Campus
Holland Community Hospital
Borgess Medical Center
Bronson Methodist Hospital
West Michigan Cancer Center
Upper Michigan Cancer Center at Marquette General Hospital
Hackley Hospital
Northern Michigan Hospital
Mercy Hospital
Seton Cancer Institute - Saginaw
Oncology Care Associates, P.L.L.C.
Providence Cancer Institute at Providence Hospital - Southfield Campus
Munson Medical Center
St. John Macomb Hospital
MeritCare Clinic - Bemidji
Brainerd Medical Center
Fairview Ridges Hospital
Mercy Hospital
Cancer Care Center at St. Luke's Hospital
CCOP - Duluth
Miller-Dwan Medical Center
St. Mary's - Duluth Clinic Cancer Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Hutchinson Area Health Care
Meeker County Memorial Hospital
St. John's Hospital
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Hennepin County Medical Center - Minneapolis
Fairview University Medical Center - University Campus
Chippewa County - Montevideo Hospital
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Mayo Clinic Cancer Center
CCOP - Metro-Minnesota
Cancer Care Center at Regions Hospital
Saint Francis Cancer Center
St. Joseph's Hospital
Adult and Pediatric Urology, P.L.L.P.
CentraCare Clinic - River Campus
Park Nicollet Clinic
United Hospital
Ridgeview Medical Center
Rice Memorial Hospital
Woodwinds Hospital
University of Mississippi Medical Center
Veterans Affairs Medical Center - Jackson
Regional Cancer Center at Singing River Hospital
St. Francis Medical Center
Saint Luke's Hospital
Missouri Cancer Associates
Ellis Fischel Cancer Center at University of Missouri - Columbia
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
CCOP - Kansas City
St. John's Regional Health Center
Hulston Cancer Center at Cox Medical Center South
Siteman Cancer Center at Barnes-Jewish Hospital
Missouri Baptist Cancer Center
CCOP - St. Louis-Cape Girardeau
Center for Cancer Care and Research
David C. Pratt Cancer Center at St. John's Mercy
CCOP - Montana Cancer Consortium
Great Falls Clinic
Sletten Regional Cancer Institute
Fremont Area Medical Center
Cancer Center at the Good Samaritan Health Systems
Bryan LGH Medical Center West
Cancer Resource Center - Lincoln
St. Elizabeth Regional Medical Center
CCOP - Missouri Valley Cancer Consortium
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Alegent Health - Immanuel Medical Center
Bergan Mercy Medical Center
Cancer Center at Creighton University Medical Center
Midlands Cancer Center at Midlands Community Hospital
University Medical Center of Southern Nevada
CCOP - Southern Nevada Cancer Research Foundation
Sunrise Hospital and Medical Center
Washoe Cancer Services at Washoe Medical Center - Reno
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Cancer Institute of New Jersey at the Cooper University Hospital
CCOP - Northern New Jersey
Monmouth Medical Center
South Jersey Healthcare Regional Cancer Center
Cancer Center at the Mountainside Hospital
Fox Chase Virtua Health Cancer Program - Marlton
Newark Beth Israel Medical Center
Atlantic City Medical Center - Mainland Division
Booker Cancer Center at Riverview Medical Center
Community Medical Center
Fox Chase Cancer Center at St. Francis Medical Center
Capital Health System Regional Cancer Center
Hematology-Oncology Associates, PC
University of New Mexico Cancer Research and Treatment Center
Lovelace Medical Center at Lovelace Sandia Health System
SUNY Downstate Medical Center
New York Methodist Hospital
Finger Lakes Hematology and Oncology
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Catskill Regional Medical Center
CCOP - North Shore University Hospital
New York Weill Cornell Cancer Center at Cornell University
Highland Hospital of Rochester
James P. Wilmot Cancer Center at University of Rochester Medical Center
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Crouse Hospital
Veterans Affairs Medical Center - Syracuse
Community General Hospital of Greater Syracuse
Randolph Hospital
Blumenthal Cancer Center at Carolinas Medical Center
Presbyterian Cancer Center at Presbyterian Hospital
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Wayne Memorial Hospital, Incorporated
Wayne Radiation Oncology
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Lenoir Memorial Cancer Center
Annie Penn Cancer Center
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilson Medical Center
Forsyth Regional Cancer Center at Forsyth Medical Center
Bismarck Cancer Center
Medcenter One Health System
Mid Dakota Clinic, P.C.
St. Alexius Medical Center
CCOP - MeritCare Hospital
MeritCare Medical Group
Altru Cancer Center at Altru Hospital
Trinity Cancer Care Center
Akron City Hospital at Summa Health System
McDowell Cancer Center at Akron General Medical Center
University Hospitals Ireland Cancer Center at Mercy Medical Center
Adena Regional Medical Center
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Huron Hospital Cancer Care Center
Euclid Hospital
Cleveland Clinic Taussig Cancer Center
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Riverside Cancer Services
Mount Carmel West Hospital
Doctors Hospital at Ohio Health
Grandview Hospital
Good Samaritan Hospital
Miami Valley Hospital
Samaritan North Cancer Care Center
Veterans Affairs Medical Center - Dayton
CCOP - Dayton
Grady Memorial Hospital
Charles F. Kettering Memorial Hospital
Fairfield Medical Center
St. Rita's Medical Center
Lima Memorial Hospital
Strecker Cancer Center at Marietta Memorial Hospital
St. Luke's Hospital
Hillcrest Cancer Center at Hillcrest Hospital
Middletown Regional Hospital
Licking Memorial Cancer Care Program at Licking Memorial Hospital
St. Charles Mercy Hospital
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Firelands Regional Medical Center
Mercy Medical Center Oncology Unit
Community Hospital of Springfield and Clark County
Promedica Cancer Center at Flower Hospital
Mercy Hospital of Tiffin
Toledo Hospital
St. Vincent Mercy Medical Center
Medical College of Ohio Cancer Institute
CCOP - Toledo Community Hospital
Toledo Clinic, Incorporated
UVMC Cancer Care Center at Upper Valley Medical Center
South Pointe Hospital Cancer Care Center
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Cancer Treatment Center
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Genesis - Good Samaritan Hospital
LaFortune Cancer Center at St. John Health System
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Legacy Mount Hood Medical Center
Providence Milwaukie Hospital
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Providence Cancer Center at Providence Portland Medical Center
CCOP - Columbia River Oncology Program
Providence St. Vincent Medical Center
Institute of Oncology at Vilnius University
Kaiser Permanente Health Care - Portland
Cancer Institute at Oregon Health and Science University
Salem Hospital Regional Cancer Center
Legacy Meridian Park Hospital
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
St. Luke's Hospital Cancer Center
Bryn Mawr Hospital
Geisinger Medical Center
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Penn State Cancer Institute at Milton S. Hershey Medical Center
St. Mary Regional Cancer Center
Lewistown Hospital
Cancer Center at Paoli Memorial Hospital
Joan Karnell Cancer Center at Pennsylvania Hospital
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase Cancer Center
Albert Einstein Cancer Center
Allegheny Cancer Center at Allegheny General Hospital
Mercy Hospital of Pittsburgh
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pottstown Memorial Regional Cancer Center
St. Joseph Medical Center
Guthrie Medical Center - Sayre
Mercy Hospital Cancer Center - Scranton
Geisinger Medical Group
Mount Nittany Medical Center
Reading Hospital and Medical Center
Geisinger Wyoming Valley Medical Center
CCOP - MainLine Health
Lankenau Cancer Center at Lankenau Hospital
Bon Secours St. Francis Health System
Greenville Hospital System Cancer Center
CCOP - Greenville
Rapid City Regional Hospital
Sioux Valley Hospital and University of South Dakota Medical Center
Avera McKennan Hospital and University Health Center
Medical X-Ray Center
Baptist Centers for Cancer Care
Harrington Cancer Center
St. Joseph Regional Cancer Center
Brooke Army Medical Center
M.D. Anderson Cancer Center at University of Texas
Wilford Hall Medical Center
Joe Arrington Cancer Research and Treatment Center
Veterans Affairs Medical Center - San Antonio (Murphy)
Cancer Therapy and Research Center
University Hospital - San Antonio
University of Texas Health Science Center at San Antonio
Cottonwood Hospital Medical Center
McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Utah Cancer Specialists at UCS Cancer Center
Huntsman Cancer Institute at University of Utah
LDS Hospital
Dixie Regional Medical Center
Mountainview Medical
Fletcher Allen Health Care - University Health Center Campus
Danville Regional Medical Center
Virginia Oncology Associates - Hampton
Bon Secours Cancer Care at St. Mary's Hospital
St. Joseph Hospital Community Cancer Center
Olympic Hematology and Oncology
Providence Cancer Institute at Providence Everett Medical Center - Pacific Campus
Cancer Care Center at Skagit Valley Hospital
CCOP - Virginia Mason Research Center
Fred Hutchinson Cancer Research Center
Group Health Central Hospital
Harborview Medical Center
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
University Cancer Center at University of Washington Medical Center
Cancer Care Northwest - Spokane South
Madigan Army Medical Center
Cancer Center at Southwest Washington Medical Center
Central Washington Hospital
Wenatchee Valley Clinic
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Camden-Clark Memorial Hospital
Luther Mildelfort Hospital
Midelfort Clinic - Luther
Central Wisconsin Cancer Program at Agnesian Health Care
Green Bay Oncology, Limited at St. Vincent Hospital
St. Vincent Hospital
Green Bay Oncology, Limited at St. Mary's Hospital
St. Mary's Hospital Medical Center
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
University of Wisconsin Comprehensive Cancer Center
Bay Area Cancer Care Center at Bay Area Medical Center
Marshfield Clinic - Marshfield Center
Community Memorial Hospital
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
Medical College of Wisconsin Cancer Center
Veterans Affairs Medical Center - Milwaukee (Zablocki)
All Saints Cancer Center at All Saints Healthcare
West Allis Memorial Hospital
Pretoria Academic Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003596

First Posted

November 1, 1999

Last Updated

December 30, 2016

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, SWOG Cancer Research Network, North Central Cancer Treatment Group

1. Study Identification

Unique Protocol Identification Number

NCT00003596

Brief Title

Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

Official Title

A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

October 1998 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), Eastern Cooperative Oncology Group, Cancer and Leukemia Group B, SWOG Cancer Research Network, North Central Cancer Treatment Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus radiation therapy for anal cancer. PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus radiation therapy to see how well it works compared to fluorouracil and cisplatin plus radiation therapy in treating patients with stage II or stage III anal cancer.

Detailed Description

OBJECTIVES: Compare the initial and total local and distant failure rates in patients with anal canal cancer treated with either fluorouracil (5-FU) plus mitomycin concurrently with radiotherapy or 5-FU plus cisplatin followed by 5-FU plus cisplatin concurrently with radiotherapy. Identify any differences in local control and colostomy rates at 2 years in patients treated with these regimens. Determine any difference in colostomy free, disease free, or overall survival in patients treated with these regimens. Compare the toxic effects of these regimens in these patients. Evaluate the prognostic effects of tumor markers P53 overexpression, human papilloma virus status, and enzyme HAP1 in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to gender, nodal status (positive vs negative), and primary tumor size (greater than 2 cm to 5 cm vs greater than 5 cm). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29 and mitomycin IV on days 1 and 29 with concurrent radiotherapy. Arm II: Patients receive induction chemotherapy comprising 5-FU IV continuously over 96 hours beginning on days 1, 29, 57, and 85 and cisplatin IV over 1 hour on days 1, 29, 57, and 85. Beginning on day 57, patients receive concurrent radiotherapy. In both arms, radiotherapy is administered daily, 5 days a week, for 5-6.5 weeks. Patients with T3, T4, or N+ lesions or T2 lesions with residual disease receive additional radiotherapy to a reduced field. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Cancer

Keywords

stage II anal cancer, stage III anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Allocation

Randomized

Enrollment

682 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Drug

Intervention Name(s)

mitomycin C

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: