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

21 oktober 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Colorectale kanker

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Radiation Therapy Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2001

Primaire voltooiing (Werkelijk)

1 december 2003

Studieregistratiedata

Eerst ingediend

4 oktober 2000

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2003

Eerst geplaatst (Schatting)

27 januari 2003

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 oktober 2020

Laatste update ingediend die voldeed aan QC-criteria

21 oktober 2020

Laatst geverifieerd

1 december 2002

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

RTOG-R-0012
CDR0000068239

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .