Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal
7 other identifiers
interventional
682
2 countries
485
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 1998
Longer than P75 for phase_3
485 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 4, 2017
December 1, 2016
7 years
November 1, 1999
December 30, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- Eastern Cooperative Oncology Groupcollaborator
- Cancer and Leukemia Group Bcollaborator
- SWOG Cancer Research Networkcollaborator
- North Central Cancer Treatment Groupcollaborator
Study Sites (485)
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Alaska Regional Hospital
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 85259, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72903, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94705, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505, United States
Mills-Peninsula Health Services
Burlingame, California, 94010, United States
Mount Diablo Regional Cancer Center
Concord, California, 94520, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
California Cancer Center - Woodward Park Office
Fresno, California, 93720, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, 94904, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
Saint Rose Hospital
Hayward, California, 94545, United States
Valley Memorial Hospital
Livermore, California, 94550, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804, United States
Providence Holy Cross Cancer Center
Mission Hills, California, 91346-9600, United States
Memorial Medical Center Cancer Services
Modesto, California, 95355, United States
Leavey Cancer Center at Northridge Hospital Medical Center
Northridge, California, 91325, United States
Highland General Hospital
Oakland, California, 94602, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609, United States
Summit Medical Center
Oakland, California, 94609, United States
Palo Alto Medical Foundation
Palo Alto, California, 94301, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Radiological Associates of Sacramento Medical Group, Inc.
Sacramento, California, 95815, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Naval Medical Center - San Diego
San Diego, California, 92134, United States
California Pacific Medical Center - California Campus
San Francisco, California, 94118, United States
J.C. Robinson, M.D. Regional Cancer Center
San Pablo, California, 94806, United States
CCOP - Santa Rosa Memorial Hospital
Sana Rosa, California, 95405, United States
Torrance Memorial Medical Center
Torrance, California, 90509, United States
Sutter Solano Medical Center
Vallejo, California, 94589, United States
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80524, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80502, United States
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thorton, Colorado, 80229, United States
Middlesex Hospital Cancer Center
Middletown, Connecticut, 06457, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19718, United States
St. Francis Hospital
Wilmington, Delaware, 19805, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
21st Century Oncology - Fort Myers
Fort Myers, Florida, 33901, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224-9980, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612, United States
Emory University Hospital - Atlanta
Altanta, Georgia, 30322, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, 31603, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Mountain States Tumor Institute - Boise
Boise, Idaho, 83712, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, 62002, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507, United States
Good Shepherd Hospital
Barrington, Illinois, 60010, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
St. Anthony's Memorial Hospital
Effingham, Illinois, 62401, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201, United States
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Edward Hospital Cancer Center
Naperville, Illinois, 60566, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, 61350, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Bloomington Hospital
Bloomington, Indiana, 47403, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Saint Joseph Regional Medical Center - Plymouth Campus
Plymouth, Indiana, 46544, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Union Hospital
Terre Haute, Indiana, 47804, United States
McFarland Clinic, P.C.
Ames, Iowa, 50010, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
St. Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
Genesis Medical Center - West Campus
Davenport, Iowa, 52804, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, 52001, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, 51555, United States
Burgess Health Center
Onawa, Iowa, 51040, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
South Central Kansas Regional Medical Center
Arkansas City, Kansas, 67005, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Ottawa
Ottawa, Kansas, 66067, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67042, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health
Wichita, Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Cancer Treatment Center at the Medical Center - Bowling Green
Bowling Green, Kentucky, 42101, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
Madisonville, Kentucky, 42431, United States
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, 71210, United States
Tulane Cancer Center
New Orleans, Louisiana, 70112, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71101, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, 04401, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Maine General Medical Center - Waterville
Waterville, Maine, 04901, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-8936, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118, United States
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, 01742, United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River, Massachusetts, 02721, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Newton - Wellesley Hospital
Newton, Massachusetts, 02162, United States
South Suburban Oncology Center
Quincy, Massachusetts, 02169, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48100, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Battle Creek Health System
Battle Creek, Michigan, 49017, United States
Mecosta County General Hospital
Big Rapids, Michigan, 49307, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48532, United States
Great Lakes Cancer Institute at McLaren Regional Medical Center
Flint, Michigan, 48532, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, 49503, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Metropolitan Hospital
Grand Rapids, Michigan, 49506, United States
Spectrum Health Hospital - Blodgett Campus
Grand Rapids, Michigan, 49506, United States
Holland Community Hospital
Holland, Michigan, 49423, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazooaa, Michigan, 49001, United States
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, 49855, United States
Hackley Hospital
Muskegon, Michigan, 49443, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, 48601, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, 48075, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
St. John Macomb Hospital
Warren, Michigan, 48903, United States
MeritCare Clinic - Bemidji
Bemidji, Minnesota, 56601, United States
Brainerd Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Cancer Care Center at St. Luke's Hospital
Duluth, Minnesota, 55805, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth, Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
St. John's Hospital
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455, United States
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, 56265, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Adult and Pediatric Urology, P.L.L.P.
Saint Cloud, Minnesota, 56303, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416, United States
Cancer Care Center at Regions Hospital
Saint Paul, Minnesota, 55101, United States
St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Cancer Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Woodwinds Hospital
Woodbury, Minnesota, 55125, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581, United States
St. Francis Medical Center
Cape Girardeau, Missouri, 63701, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, 63701, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Sletten Regional Cancer Institute
Great Falls, Montana, 59405, United States
Fremont Area Medical Center
Fremont, Nebraska, 68025, United States
Cancer Center at the Good Samaritan Health Systems
Kearney, Nebraska, 68847, United States
Bryan LGH Medical Center West
Lincoln, Nebraska, 68502, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
Alegent Health - Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Cancer Center at Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68046, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Washoe Cancer Services at Washoe Medical Center - Reno
Reno, Nevada, 89502, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, 08103, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
South Jersey Healthcare Regional Cancer Center
Millville, New Jersey, 08332, United States
Cancer Center at the Mountainside Hospital
Montclair, New Jersey, 07042, United States
Fox Chase Virtua Health Cancer Program - Marlton
Mount Holly, New Jersey, 08060, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Atlantic City Medical Center - Mainland Division
Pomona, New Jersey, 08240, United States
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, 08611, United States
Capital Health System Regional Cancer Center
Trenton, New Jersey, 08618, United States
Hematology-Oncology Associates, PC
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87106, United States
Lovelace Medical Center at Lovelace Sandia Health System
Albuquerque, New Mexico, 87108, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Finger Lakes Hematology and Oncology
Clifton Springs, New York, 14432, United States
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Catskill Regional Medical Center
Harris, New York, 12742, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021, United States
Highland Hospital of Rochester
Rochester, New York, 14620, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13057, United States
Crouse Hospital
Syracuse, New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210, United States
Community General Hospital of Greater Syracuse
Syracuse, New York, 13215, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233, United States
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, 27288, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, 27401, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, 28501, United States
Annie Penn Cancer Center
Reidsville, North Carolina, 27320, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Wilson Medical Center
Wilson, North Carolina, 27893, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Medcenter One Health System
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Medical Group
Fargo, North Dakota, 58122, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
Akron City Hospital at Summa Health System
Akron, Ohio, 44304, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
University Hospitals Ireland Cancer Center at Mercy Medical Center
Canton, Ohio, 44708, United States
Adena Regional Medical Center
Chillicothe, Ohio, 54601, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Huron Hospital Cancer Care Center
Cleveland, Ohio, 44112, United States
Euclid Hospital
Cleveland, Ohio, 44119, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Riverside Cancer Services
Columbus, Ohio, 43215, United States
Mount Carmel West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
St. Luke's Hospital
Maumee, Ohio, 43537, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Middletown Regional Hospital
Middletown, Ohio, 45044, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460, United States
Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Mercy Medical Center Oncology Unit
Springfield, Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical College of Ohio Cancer Institute
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated
Toledo, Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373, United States
South Pointe Hospital Cancer Care Center
Warrensville Heights, Ohio, 44122, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, 43081, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
LaFortune Cancer Center at St. John Health System
Tulsa, Oklahoma, 74104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Legacy Mount Hood Medical Center
Glesham, Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Institute of Oncology at Vilnius University
Portland, Oregon, 97227, United States
Kaiser Permanente Health Care - Portland
Portland, Oregon, 97232, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239, United States
Salem Hospital Regional Cancer Center
Salem, Oregon, 97309, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Cancer Center at Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224-1791, United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464, United States
St. Joseph Medical Center
Reading, Pennsylvania, 19604, United States
Guthrie Medical Center - Sayre
Sayre, Pennsylvania, 18840, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19612, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, 29601, United States
Greenville Hospital System Cancer Center
Greenville, South Carolina, 29605, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Baptist Centers for Cancer Care
Memphis, Tennessee, 38146, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
St. Joseph Regional Cancer Center
Bryan, Texas, 77802, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78209, United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229, United States
University Hospital - San Antonio
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84603, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
Mountainview Medical
Berlin Corners, Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Virginia Oncology Associates - Hampton
Hampton, Virginia, 23666, United States
Bon Secours Cancer Care at St. Mary's Hospital
Richmond, Virginia, 23226, United States
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton, Washington, 98310, United States
Providence Cancer Institute at Providence Everett Medical Center - Pacific Campus
Everett, Washington, 98201, United States
Cancer Care Center at Skagit Valley Hospital
Mount Vernon, Washington, 98273, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104, United States
Group Health Central Hospital
Seattle, Washington, 98104, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98114, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Cancer Center at Southwest Washington Medical Center
Vancouver, Washington, 98668, United States
Central Washington Hospital
Wenatchee, Washington, 98801, United States
Wenatchee Valley Clinic
Wenatchee, Washington, 98801, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26101, United States
Luther Mildelfort Hospital
Eau Claire, Wisconsin, 54702, United States
Midelfort Clinic - Luther
Eau Claire, Wisconsin, 54702, United States
Central Wisconsin Cancer Program at Agnesian Health Care
Fond du Lac, Wisconsin, 54935, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405, United States
West Allis Memorial Hospital
West Allis, Wisconsin, 53227, United States
Pretoria Academic Hospital
Pretoria, South Africa
Related Publications (10)
Ben-Josef E, Moughan J, Ajani JA, Flam M, Gunderson L, Pollock J, Myerson R, Anne R, Rosenthal SA, Willett C. Impact of overall treatment time on survival and local control in patients with anal cancer: a pooled data analysis of Radiation Therapy Oncology Group trials 87-04 and 98-11. J Clin Oncol. 2010 Dec 1;28(34):5061-6. doi: 10.1200/JCO.2010.29.1351. Epub 2010 Oct 18.
PMID: 20956625BACKGROUNDGlynne-Jones R, Mawdsley S. Anal cancer: is neoadjuvant cisplatin chemotherapy or chemoradiotherapy friend or foe? Nat Clin Pract Oncol. 2008 Dec;5(12):692-3. doi: 10.1038/ncponc1258. Epub 2008 Oct 14.
PMID: 18852720BACKGROUNDGunderson LL, Winter KA, Ajani JA, et al.: Long-term update of U.S. GI intergroup RTOG 98-11 phase III trial for anal carcinoma: disease-free and overall survival with RT+5FU-mitomycin versus RT+5FU-cisplatin. [Abstract] J Clin Oncol 29 (Suppl 15): A-4005, 2011.
RESULTAjani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Prognostic factors derived from a prospective database dictate clinical biology of anal cancer: the intergroup trial (RTOG 98-11). Cancer. 2010 Sep 1;116(17):4007-13. doi: 10.1002/cncr.25188.
PMID: 20564111RESULTGunderson LL, Moughan J, Ajani JA, et al.: Anal carcinoma: Impact of TN category of disease on survival, disease relapse, and colostomy failure in U.S. GI Intergroup RTOG 98-11 phase III trial. [Abstract] American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, 22-24 January 2010, Orlando, Florida. A-285, 2010.
RESULTAjani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. US intergroup anal carcinoma trial: tumor diameter predicts for colostomy. J Clin Oncol. 2009 Mar 1;27(7):1116-21. doi: 10.1200/JCO.2008.19.6857. Epub 2009 Jan 12.
PMID: 19139424RESULTAjani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett C. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008 Apr 23;299(16):1914-21. doi: 10.1001/jama.299.16.1914.
PMID: 18430910RESULTAjani JA, Winter KA, Gunderson LL, et al.: Intergroup RTOG 98-11: a phase III randomized study of 5-fluorouracil (5-FU), mitomycin, and radiotherapy versus 5-fluorouracil, cisplatin and radiotherapy in carcinoma of the anal canal. [Abstract] J Clin Oncol 24 (Suppl 18): A-4009, 2006.
RESULTGunderson LL, Winter KA, Ajani JA, et al.: Intergroup RTOG 9811 phase III comparison of chemoradiation with 5-FU and mitomycin vs 5-FU and cisplatin for anal canal carcinoma: impact on disease-free, overall and colostomy-free survival. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-43, S24, 2006.
RESULTGunderson LL, Winter KA, Ajani JA, Pedersen JE, Moughan J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Long-term update of US GI intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012 Dec 10;30(35):4344-51. doi: 10.1200/JCO.2012.43.8085. Epub 2012 Nov 13.
PMID: 23150707DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jaffer A. Ajani, MD
M.D. Anderson Cancer Center
- STUDY CHAIR
Al B. Benson, MD, FACP
Robert H. Lurie Cancer Center
- STUDY CHAIR
Joel E. Tepper, MD
UNC Lineberger Comprehensive Cancer Center
- STUDY CHAIR
John S. MacDonald, MD
Beth Israel Comprehensive Cancer Center - West Side Campus
- STUDY CHAIR
Michael G. Haddock, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
October 1, 1998
Primary Completion
October 1, 2005
Study Completion
December 1, 2016
Last Updated
January 4, 2017
Record last verified: 2016-12