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

2020年10月21日更新者：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.

研究概览

地位

完全的

条件

大肠癌

干预/治疗

详细说明

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.

研究类型

介入性

阶段

阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Radiation Therapy Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2001年2月1日

初级完成 (实际的)

2003年12月1日

研究注册日期

首次提交

2000年10月4日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (实际的)

2020年10月22日

上次提交的符合 QC 标准的更新

2020年10月21日

最后验证

2002年12月1日