Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00006366
First received: October 4, 2000
Last updated: July 17, 2013
Last verified: December 2002
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy plus chemotherapy is more effective for rectal cancer.

PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: irinotecan hydrochloride
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: February 2001
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the pathological complete response, acute and late normal tissue morbidity, patterns of failure, and complete resection rates in patients with locally advanced adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy comprised of hyperfractionated radiotherapy and fluorouracil vs conventional radiotherapy, fluorouracil, and irinotecan, followed by radical resection.

OUTLINE: This is a randomized study. Patients are stratified according to clinical stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive hyperfractionated radiotherapy (RT) twice daily, 5 days a week for 19 days. Patients receive fluorouracil IV continuously over 7 days a week concurrently with RT. Patients with clinical stage T3 or fixed T4 disease also receive a higher boost dose of RT to tumor.
  • Arm II: Patients receive conventional RT once daily, 5 days a week for 25 days. Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT. Patients receive irinotecan IV over 1 hour (immediately prior to RT dose) once weekly for 4 weeks. Patients with clinical stage T3 or fixed T4 disease also receive a lower boost dose of RT to tumor.

Within 4-10 weeks after completion of chemoradiotherapy, patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the distal rectum

    • Located 0-9 cm from the dentate line (3-12 cm from the anal verge)

      • No extension of malignant disease into the anal canal
  • Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation
  • No evidence of distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC (white blood cell count) greater than 4,000/mm^3
  • Platelet count greater than 130,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal
  • Alkaline phosphatase, SGOT (serum glutamic oxaloacetic transaminase), and LDH (lactate dehydrogenase) normal

Renal:

  • Creatinine normal

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 5 years except:

    • Inactive nonmelanomatous skin cancer
    • Carcinoma in situ of the cervix
    • Synchronous colonic cancer if tumor is Tis or T1 and has been completely resected
  • No other serious medical illnesses

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to pelvis

Surgery:

  • Not specified

Other:

  • No concurrent antiepileptic drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006366

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
Huntsville Hospital System
Huntsville, Alabama, United States, 35807
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-3657
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
United States, California
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
California Cancer Center
Fresno, California, United States, 93729-5100
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Sutter Health West Cancer Research Group
Greenbrae, California, United States, 94904
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90025-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Huntington Cancer Center
Pasadena, California, United States, 91105
Cancer Care Center
Pomona, California, United States, 91767
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
Radiation Medical Group, Inc.
San Diego, California, United States, 92101
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
O'Connor Hospital
San Jose, California, United States, 95128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Saint Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502-1628
United States, Connecticut
Hospital of St. Raphael
New Haven, Connecticut, United States, 06511
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Florida Radiation Oncology Group
Jacksonville, Florida, United States, 32207
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901-3276
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Bay Medical Center
Panama City, Florida, United States, 32401
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Sarasota Radiation and Medical Oncology Center
Sarasota, Florida, United States, 34233
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States, 32308
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Medical Center/John B. Amos Community Cancer Center
Columbus, Georgia, United States, 31901
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
St. John's Medical Center
Anderson, Indiana, United States, 46016
Bloomington Hospital
Bloomington, Indiana, United States, 47402
Clarian Health Partners Inc.
Indianapolis, Indiana, United States, 46206-1367
Regional Cancer Center
Indianapolis, Indiana, United States, 46219
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States, 52001
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0293
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Louisville Radiation Oncology
Louisville, Kentucky, United States, 40215
Merle M. Mahr Cancer Center
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Anne Arundel Oncology Center
Annapolis, Maryland, United States, 21401
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
Harbor Hospital Center
Baltimore, Maryland, United States, 21215-1290
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
McLaren Regional Cancer Center
Flint, Michigan, United States, 48532-3685
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
Marquette General Hospital
Marquette, Michigan, United States, 49855
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63108
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
Nebraska Health System
Omaha, Nebraska, United States, 68198-7460
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
South Jersey Regional Cancer Center
Millville, New Jersey, United States, 08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 38103-2807
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Community Medical Center
Toms River, New Jersey, United States, 08755
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
Associated Radiologists, P.A.
Warren, New Jersey, United States, 07059
United States, New Mexico
Radiation Oncology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Finger Lakes Radiation Oncology Center
Clifton Springs, New York, United States, 14432
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Riverhill Radiation Oncology
Yonkers, New York, United States, 10701
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Northeast Medical Center
Concord, North Carolina, United States, 28025
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45267-0502
Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
CCOP - Columbus
Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Dayton
Kettering, Ohio, United States, 45429
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
St. Anthony Hospital
Oklahoma City, Oklahoma, United States, 73101
St. John Health System
Tulsa, Oklahoma, United States, 74104
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Pocono Cancer Center
East Stroudsburg, Pennsylvania, United States, 18301
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Veterans Affairs Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141-3098
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Wilkes Barre General Hospital
Wilkes-Barre, Pennsylvania, United States, 18764
York Hospital
York, Pennsylvania, United States, 17315
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301-3956
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38103
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5671
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Bayshore Medical Center
Pasadena, Texas, United States, 77504
United States, Utah
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
RMH Regional Cancer Center
Harrisonburg, Virginia, United States, 22801
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Bon-Secours - St. Mary's Hospital
Richmond, Virginia, United States, 23226
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
All Saints Cancer Center
Racine, Wisconsin, United States, 53405
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4MI
McGill University
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Mohammed M. Mohiuddin, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Additional Information:
Publications:
Mohiuddin M, Garcia M, Mitchell E, et al.: 3-year results of RTOG-0012 randomized phase II study of neoadjuvant combined modality chemoradiation for distal rectal cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2092, S260, 2006.
Mitchell EP, Winter K, Mohiuddin M, et al.: Randomized phase II trial of preoperative combined modality chemoradiation for distal rectal cancer. [Abstract] J Clin Oncol 22 (Suppl 14): A-3535, 253s, 2004.
Mohiuddin M, Winter K, Mitchell E, et al.: Results of RTOG-0012 randomized phase II study of neoadjuvant combined modality chemoradiation for distal rectal cancer. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-16, S138, 2004.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00006366     History of Changes
Other Study ID Numbers: RTOG-R-0012, CDR0000068239, RTOG-DEV-1030
Study First Received: October 4, 2000
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Fluorouracil
Irinotecan
Camptothecin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014