Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

December 31, 2016

Conditions
Colorectal Cancer
Interventions
DRUG

capecitabine

1650 mg/m\^2/day orally 5 days/week during radiotherapy.

DRUG

oxaliplatin

PROCEDURE

resection

All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.

RADIATION

radiation therapy

Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx

DRUG

FOLFOX

"Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m\^2, IV over 2 hours, day 1.~Leucovorin 400 mg/m\^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m\^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m\^2, IV continuous infusion over 46 hours, day 1."

Trial Locations (120)

11030

CCOP - North Shore University Hospital, Manhasset

Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11042

Monter Cancer Center of the North Shore-LIJ Health System, Lake Success

11219

Maimonides Cancer Center at Maimonides Medical Center, Brooklyn

18301

Dale and Frances Hughes Cancer Center at Pocono Medical Center, East Stroudsburg

18337

Upper Delaware Valley Cancer Center, Milford

18512

Northeast Radiation Oncology Center, Dunmore

19001

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington

19010

Bryn Mawr Hospital, Bryn Mawr

19063

Riddle Memorial Hospital Cancer Center, Media

19096

CCOP - Main Line Health, Wynnewood

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19114

Frankford Hospital Cancer Center - Torresdale Campus, Philadelphia

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

24273

Southwest Virginia Regional Cancer Center at Wellmonth Health, Norton

27534

Wayne Memorial Hospital, Incorporated, Goldsboro

Wayne Radiation Oncology, Goldsboro

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

30309

Piedmont Hospital, Atlanta

31904

John B. Amos Cancer Center, Columbus

32073

Integrated Community Oncology Network - Orange Park, Orange Park

32207

Baptist Cancer Institute - Jacksonville, Jacksonville

32401

Bay Medical, Panama City

33176

Baptist-South Miami Regional Cancer Program, Miami

33486

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

36608

Providence Cancer Center at Providence Hospital, Mobile

37662

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

39581

Regional Cancer Center at Singing River Hospital, Pascagoula

44203

Barberton Citizens Hospital, Barberton

44460

Cancer Care Center, Incorporated, Salem

44691

Cancer Treatment Center, Wooster

45069

Precision Radiotherapy at University Pointe, West Chester

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

46016

Saint John's Cancer Center at Saint John's Medical Center, Anderson

46260

St. Vincent Oncology Center, Indianapolis

46526

Center for Cancer Care at Goshen General Hospital, Goshen

53097

Columbia Saint Mary's Hospital - Ozaukee, Mequon

53211

Columbia-Saint Mary's Cancer Care Center, Milwaukee

53226

Medical College of Wisconsin Cancer Center, Milwaukee

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology, PA - Maplewood, Maplewood

55125

Minnesota Oncology Hematology, PA - Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55379

St. Francis Cancer Center at St. Francis Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

Park Nicollet Cancer Center, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

62702

Cancer Institute at St. John's Hospital, Springfield

63110

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

63141

Barnes-Jewish West County Hospital, St Louis

63376

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

63703

Cancer Institute of Cape Girardeau, LLC, Cape Girardeau

64068

Liberty Hospital, Liberty

64086

Saint Luke's East - Lee's Summit, Lee's Summit

64108

Truman Medical Center - Hospital Hill, Kansas City

64111

Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City

64114

St. Joseph Medical Center, Kansas City

64116

North Kansas City Hospital, Kansas City

Parvin Radiation Oncology, Kansas City

64131

CCOP - Kansas City, Kansas City

64132

Research Medical Center, Kansas City

64506

Heartland Regional Medical Center, Saint Joseph

65802

CCOP - Cancer Research for the Ozarks, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

66204

Shawnee Mission Medical Center, Shawnee Mission

66209

Menorah Medical Center, Overland Park

66213

Saint Luke's Hospital - South, Overland Park

68198

Nebraska Medical Center, Omaha

73104

Oklahoma University Cancer Institute, Oklahoma City

73112

Integris Oncology Services, Oklahoma City

84003

American Fork Hospital, American Fork

84103

LDS Hospital, Salt Lake City

84106

Utah Cancer Specialists at UCS Cancer Center, 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

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

89502

Renown Institute for Cancer at Renown Regional Medical Center, Reno

92161

Veterans Affairs Medical Center - San Diego, San Diego

93720

California Cancer Center - Woodward Park Office, Fresno

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

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

92093-0658

Rebecca and John Moores UCSD Cancer Center, La Jolla

32610-0232

University of Florida Shands Cancer Center, Gainesville

31403-3089

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah

47303-3499

Cancer Center at Ball Memorial Hospital, Muncie

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber/Brigham and Women's Cancer Center, Boston

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston

02118

Boston University Cancer Research Center, Boston

02721

Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River

55422-2900

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale

03431

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene

03756-0002

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

07740-6395

Monmouth Medical Center, Long Branch

08053

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

08755

J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

43210-1240

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus

17033-0850

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey

19301-1792

Cancer Center of Paoli Memorial Hospital, Paoli

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

02903

Rhode Island Hospital Comprehensive Cancer Center, Providence

05819

Norris Cotton Cancer Center - North, Saint Johnsbury

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK