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

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

February 28, 2009

Study Completion Date

December 31, 2016

Conditions
Anal Cancer
Interventions
DRUG

fluorouracil

1000 mg/m\^2/day 96-hour continous infusion (M-F) starting on day 1 and again on day 29 of radiation therapy.

DRUG

mitomycin C

10 mg/m\^2 intravenous therapy on day 1 and day 29 of radiation therapy.

RADIATION

Intensity-modulated radiation therapy

"Prescription dose depends on tumor staging.~T2N0: The primary tumor PTV (planning target volume) (PTVA) receives 50.4 Gy in 28 fractions (fx) at 1.8 Gy/fx. The nodal PTVs receive 42 Gy in 28 fx at 1.5 Gy/fx. PTVA receive 50.4 Gy in 28 fractions at 1.8 Gy/fx. PTV42 receive 42 Gy in 28 fx at 1.5 Gy/fx and will include all nodal regions.~T3N0 or T4N0: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. The nodal PTVs will receive 45 Gy in 30 fx at 1.5 Gy/fx. PTVA will receive 54 Gy in 30 fx at 1.80 Gy/fx. PTV45 will receive 45 Gy in 30 fx electively at 1.5 Gy/fx and will include all nodal regions.~For N+ disease: The primary tumor PTV (PTVA) will receive 54 Gy in 30 fx at 1.8 Gy/fx. For involved nodes ≤ 3 cm in maximum dimension, the involved nodal PTV will receive 50.4 Gy in 30 fx at 1.68 Gy/fx. For involved nodes \> 3 cm in maximum dimension, the involved nodal PTV will receive 54 Gy in 30 fx at 1.80 Gy/fx."

Trial Locations (172)

13057

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

14642

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester

18015

St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem

19010

Bryn Mawr Hospital, Bryn Mawr

19026

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill

19096

CCOP - MainLine Health, Wynnewood

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19114

Frankford Hospital Cancer Center - Torresdale Campus, Philadelphia

19141

Albert Einstein Cancer Center, Philadelphia

19713

CCOP - Christiana Care Health Services, Newark

19958

Tunnell Cancer Center at Beebe Medical Center, Lewes

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

21921

Union Hospital Cancer Program at Union Hospital, Elkton

24273

Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton

26003

Schiffler Cancer Center at Wheeling Hospital, Wheeling

27534

Wayne Memorial Hospital, Incorporated, Goldsboro

Wayne Radiation Oncology, Goldsboro

27893

Wilmed Radiation Oncology Services, Wilson

30309

Piedmont Hospital, Atlanta

32073

Florida Oncology Associates, Orange Park

32086

Flagler Cancer Center, Saint Augustine

32177

Florida Cancer Center - Palatka, Palatka

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

Integrated Community Oncology Network at Southside Cancer Center, Jacksonville

32250

Integrated Community Oncology Network, Jacksonville Beach

32258

Baptist Medical Center South, Jacksonville

32401

Bay Medical, Panama City

33140

CCOP - Mount Sinai Medical Center, Miami Beach

33308

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

33458

Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter

33486

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

37662

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

44307

McDowell Cancer Center at Akron General Medical Center, Akron

44460

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

44691

Cancer Treatment Center, Wooster

45069

Precision Radiotherapy at University Pointe, West Chester

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

45385

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

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital, Dayton

45409

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

45415

Samaritan North Cancer Care Center, Dayton

45428

Veterans Affairs Medical Center - Dayton, Dayton

45429

CCOP - Dayton, Dayton

Charles F. Kettering Memorial Hospital, Kettering

45840

Blanchard Valley Medical Associates, Findlay

46107

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

46202

Methodist Cancer Center at Methodist Hospital, Indianapolis

46219

Central Indiana Cancer Centers - East, Indianapolis

46260

St. Vincent Oncology Center, Indianapolis

47374

Reid Hospital & Health Care Services, Richmond

48060

Mercy Regional Cancer Center at Mercy Hospital, Port Huron

48093

St. John Macomb Hospital, Warren

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48154

St. Mary Mercy Hospital, Livonia

48236

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

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

49201

Foote Memorial Hospital, Jackson

49431

Green Bay Oncology, Limited - Escanaba, Escanaba

49801

Dickinson County Healthcare System, Iron Mountain

53226

Medical College of Wisconsin Cancer Center, Milwaukee

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54154

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls

54235

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay

54303

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

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

55905

Mayo Clinic Cancer Center, Rochester

60005

Northwest Community Hospital, Arlington Heights

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

61350

Community Hospital of Ottawa, Ottawa

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

61354

Illinois Valley Community Hospital, Peru

61356

Perry Memorial Hospital, Princeton

61362

St. Margaret's Hospital, Spring Valley

Valley Cancer Center, Spring Valley

61401

Galesburg Clinic, PC, Galesburg

Galesburg Cottage Hospital, Galesburg

InterCommunity Cancer Center of Western Illinois, Galesburg

61443

Kewanee Hospital, Kewanee

61455

McDonough District Hospital, Macomb

61520

Graham Hospital, Canton

61530

Eureka Community Hospital, Eureka

61554

Cancer Treatment Center at Pekin Hospital, Pekin

61615

CCOP - Illinois Oncology Research Association, Peoria

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

61636

Methodist Medical Center of Illinois, Peoria

61701

St. Joseph Medical Center, Bloomington

61747

Hopedale Medical Complex, Hopedale

61761

BroMenn Regional Medical Center, Normal

Community Cancer Center, Normal

62321

Memorial Hospital, Carthage

62644

Mason District Hospital, Havana

62702

Cancer Institute at St. John's Hospital, Springfield

63110

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

63376

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters, City of Saint Peters

64131

CCOP - Kansas City, Kansas City

Kansas City Cancer Centers - South, Kansas City

65802

CCOP - Cancer Research for the Ozarks, Springfield

65804

St. John's Regional Health Center, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

66210

Kansas City Cancer Centers - Southwest, Overland Park

75090

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

75230

Medical City Dallas Hospital, Dallas

75237

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

76104

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital, Fort Worth

77479

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

80045

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

80220

Veterans Affairs Medical Center - Denver, Denver

80933

Penrose Cancer Center at Penrose Hospital, Colorado Springs

81004

St. Mary - Corwin Regional Medical Center, Pueblo

84003

American Fork Hospital, American Fork

84103

LDS Hospital, Salt Lake City

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84157

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray

84403

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

84604

Utah Valley Regional Medical Center - Provo, Provo

84720

Sandra L. Maxwell Cancer Center, Cedar City

84770

Dixie Regional Medical Center - East Campus, St. George

85704

Arizona Oncology - Tucson, Tucson

87109

New Mexico Cancer Center, Albuquerque

91505

Providence Saint Joseph Medical Center - Burbank, Burbank

95603

Auburn Radiation Oncology, Auburn

95608

Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael

95661

Radiation Oncology Center - Roseville, Roseville

95682

Radiation Oncology Centers - Cameron Park, Cameron Park

95687

Solano Radiation Oncology Center, Vacaville

95815

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento

95819

Mercy General Hospital, Sacramento

97401

Willamette Valley Cancer Center - Eugene, Eugene

98003

St. Francis Hospital, Federal Way

98033

Cascade Cancer Center at Evergreen Hospital Medical Center, Kirkland

98101

CCOP - Virginia Mason Research Center, Seattle

98310

Harrison Medical Center, Bremerton

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

60611-3013

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

61615-7827

OSF St. Francis Medical Center, Peoria

02118

Boston University Cancer Research Center, Boston

48106-0995

Saint Joseph Mercy Cancer Center, Ann Arbor

48109-0942

University of Michigan Comprehensive Cancer Center, Ann Arbor

48123-2500

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49007-3731

West Michigan Cancer Center, Kalamazoo

48912-1811

Sparrow Regional Cancer Center, Lansing

48341-2985

St. Joseph Mercy Oakland, Pontiac

03431

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

08103

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

07740-6395

Monmouth Medical Center, Long Branch

08053

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton

07871

Frederick R. and Betty M. Smith Cancer Treatment Center, Sparta

08360

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

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

45005-1066

Middletown Regional Hospital, Franklin

45373-1300

UVMC Cancer Care Center at Upper Valley Medical Center, Troy

19301-1792

Cancer Center of Paoli Memorial Hospital, Paoli

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

19612-6052

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading

05819

Norris Cotton Cancer Center - North, Saint Johnsbury

54301-3526

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

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

T2N 4N2

Tom Baker Cancer Centre - Calgary, Calgary

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

H2L 4M1

Hopital Notre-Dame du CHUM, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK