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

21. oktober 2020 oppdatert av: Radiation Therapy Oncology Group

Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer

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.

Studieoversikt

Status

Fullført

Forhold

Tykktarmskreft

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Fase

Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radiation Therapy Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Mohammed M. Mohiuddin, MD, Lucille P. Markey Cancer Center at University of Kentucky

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Mohiuddin M, Paulus R, Mitchell E, Hanna N, Yuen A, Nichols R, Yalavarthi S, Hayostek C, Willett C. Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):523-8. doi: 10.1016/j.ijrobp.2013.02.020. Epub 2013 Mar 29.
Mohiuddin M, Winter K, Mitchell E, Hanna N, Yuen A, Nichols C, Shane R, Hayostek C, Willett C; Radiation Therapy Oncology Group Trial 0012. Randomized phase II study of neoadjuvant combined-modality chemoradiation for distal rectal cancer: Radiation Therapy Oncology Group Trial 0012. J Clin Oncol. 2006 Feb 1;24(4):650-5. doi: 10.1200/JCO.2005.03.6095.
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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2001

Primær fullføring (Faktiske)

1. desember 2003

Datoer for studieregistrering

Først innsendt

4. oktober 2000

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2020

Sist bekreftet

1. desember 2002

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

RTOG-R-0012
CDR0000068239

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .