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Spots Global Cancer Trial Database for Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

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Trial Identification

Brief Title: Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer

Official Title: A Phase II Evaluation of Dose-Painted Intensity-Modulated Radiation Therapy (IMRT) in Combination With 5-Fluorouracil (5-FU) and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal

Study ID: NCT00423293

Conditions

Anal Cancer

Study Description

Brief Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with 5-fluorouracil (5-FU) and mitomycin C may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy together with fluorouracil and mitomycin C works in treating patients with invasive anal cancer.

Detailed Description: OBJECTIVES: Primary * Determine if dose-painted, intensity-modulated radiation therapy (IMRT), fluorouracil, and mitomycin C decreases the combined rate of gastrointestinal and genitourinary adverse events (grade II or greater) by at least 15% in the first 90 days after the start of treatment in patients with primary invasive carcinoma of the anal canal compared to patients treated on the radiotherapy, fluorouracil, and mitomycin C arm on clinical trial RTOG 98-11. Secondary * Determine the feasibility of performing IMRT in these patients in a cooperative group setting. * Evaluate adverse events experienced by patients treated with this regimen and to decrease the grade 2 and higher and grade 3 and higher overall adverse event rates by 15% or 20% as compared to the radiotherapy and mitomycin C arm of RTOG 98-11. * Evaluate the total duration of radiotherapy. * Evaluate the efficacy of this regimen, in terms of locoregional failure, disease-free survival, time to colostomy, colostomy-free survival, and overall survival of these patients. * Determine clinical complete response at 8 weeks after completion of study treatment. OUTLINE: This is a multicenter study. Patients receive mitomycin C IV over 10-30 minutes on days 1 and 29 and fluorouracil IV continuously over 96 hours on days 1-4 and 29-32. Patients also undergo dose-painted intensity-modulated radiation therapy once daily, 5 days a week, for 5½ to 6 weeks beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 59 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arizona Oncology - Tucson, Tucson, Arizona, United States

Auburn Radiation Oncology, Auburn, California, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

Radiation Oncology Centers - Cameron Park, Cameron Park, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

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

Radiation Oncology Center - Roseville, Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States

Mercy General Hospital, Sacramento, California, United States

Solano Radiation Oncology Center, Vacaville, California, United States

University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado, United States

St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital, Boca Raton, Florida, United States

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida, United States

Integrated Community Oncology Network, Jacksonville Beach, Florida, United States

Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States

Integrated Community Oncology Network at Southside Cancer Center, Jacksonville, Florida, United States

Baptist Medical Center South, Jacksonville, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States

Florida Oncology Associates, Orange Park, Florida, United States

Florida Cancer Center - Palatka, Palatka, Florida, United States

Bay Medical, Panama City, Florida, United States

Flagler Cancer Center, Saint Augustine, Florida, United States

Piedmont Hospital, Atlanta, Georgia, United States

Northwest Community Hospital, Arlington Heights, Illinois, United States

St. Joseph Medical Center, Bloomington, Illinois, United States

Graham Hospital, Canton, Illinois, United States

Memorial Hospital, Carthage, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

Eureka Community Hospital, Eureka, Illinois, United States

Galesburg Clinic, PC, Galesburg, Illinois, United States

Galesburg Cottage Hospital, Galesburg, Illinois, United States

InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois, United States

Mason District Hospital, Havana, Illinois, United States

Hopedale Medical Complex, Hopedale, Illinois, United States

Kewanee Hospital, Kewanee, Illinois, United States

McDonough District Hospital, Macomb, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States

BroMenn Regional Medical Center, Normal, Illinois, United States

Community Cancer Center, Normal, Illinois, United States

Community Hospital of Ottawa, Ottawa, Illinois, United States

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States

OSF St. Francis Medical Center, Peoria, Illinois, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States

Methodist Medical Center of Illinois, Peoria, Illinois, United States

Illinois Valley Community Hospital, Peru, Illinois, United States

Perry Memorial Hospital, Princeton, Illinois, United States

St. Margaret's Hospital, Spring Valley, Illinois, United States

Valley Cancer Center, Spring Valley, Illinois, United States

Cancer Institute at St. John's Hospital, Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States

Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States

Central Indiana Cancer Centers - East, Indianapolis, Indiana, United States

St. Vincent Oncology Center, Indianapolis, Indiana, United States

Reid Hospital & Health Care Services, Richmond, Indiana, United States

Kansas City Cancer Centers - Southwest, Overland Park, Kansas, United States

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States

Union Hospital Cancer Program at Union Hospital, Elkton, Maryland, United States

Boston University Cancer Research Center, Boston, Massachusetts, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Dickinson County Healthcare System, Iron Mountain, Michigan, United States

Foote Memorial Hospital, Jackson, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

Sparrow Regional Cancer Center, Lansing, Michigan, United States

St. Mary Mercy Hospital, Livonia, Michigan, United States

St. Joseph Mercy Oakland, Pontiac, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States

St. John Macomb Hospital, Warren, Michigan, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Kansas City, Kansas City, Missouri, United States

Kansas City Cancer Centers - South, Kansas City, Missouri, United States

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis, Saint Louis, Missouri, United States

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters, Saint Peters, Missouri, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

St. John's Regional Health Center, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene, New Hampshire, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden, New Jersey, United States

Monmouth Medical Center, Long Branch, New Jersey, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States

Frederick R. and Betty M. Smith Cancer Treatment Center, Sparta, New Jersey, United States

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, United States

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States

New Mexico Cancer Center, Albuquerque, New Mexico, United States

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Wayne Radiation Oncology, Goldsboro, North Carolina, United States

Wilmed Radiation Oncology Services, Wilson, North Carolina, United States

McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States

Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Cancer Care Center, Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

Blanchard Valley Medical Associates, Findlay, Ohio, United States

Middletown Regional Hospital, Franklin, Ohio, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States

Precision Radiotherapy at University Pointe, West Chester, Ohio, United States

Cancer Treatment Center, Wooster, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States

Willamette Valley Cancer Center - Eugene, Eugene, Oregon, United States

St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem, Pennsylvania, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States

Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States

Frankford Hospital Cancer Center - Torresdale Campus, Philadelphia, Pennsylvania, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport, Tennessee, United States

Medical City Dallas Hospital, Dallas, Texas, United States

Texas Oncology, PA at Texas Cancer Center Dallas Southwest, Dallas, Texas, United States

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth, Texas, United States

Texas Oncology, PA at Texas Cancer Center - Sherman, Sherman, Texas, United States

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas, United States

American Fork Hospital, American Fork, Utah, United States

Sandra L. Maxwell Cancer Center, Cedar City, Utah, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah, United States

Dixie Regional Medical Center - East Campus, Saint George, Utah, United States

LDS Hospital, Salt Lake City, Utah, United States

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah, United States

Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, United States

Norris Cotton Cancer Center - North, Saint Johnsbury, Vermont, United States

Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton, Virginia, United States

Harrison Medical Center, Bremerton, Washington, United States

St. Francis Hospital, Federal Way, Washington, United States

Cascade Cancer Center at Evergreen Hospital Medical Center, Kirkland, Washington, United States

CCOP - Virginia Mason Research Center, Seattle, Washington, United States

Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States

Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States

Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada

Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada

Contact Details

Name: Lisa A. Kachnic, MD

Affiliation: Boston Medical Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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