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Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluorouracil
leucovorin calcium
conventional surgery
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage I rectal cancer, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the rectum T1 or T2 by physical and endoscopic exams No T3 lesions by clinical or radiological exam Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer No multi-focal disease within the rectum at time of initial diagnosis No non-adenocarcinomatous rectal cancer or anal cancer Less than 4 cm at greatest diameter Less than 40% of rectal wall circumference involved Proximal margin no greater than 8 cm from dentate line No tumor fixation to the perirectal tissues regardless of size No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging No palpable perirectal lymph nodes or nodes larger than 1 cm No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.8 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins Prior incision or operative biopsy or colonoscopic removal allowed

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • MBCCOP - Gulf Coast
  • CCOP - Greater Phoenix
  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  • Veterans Affairs Medical Center - Tucson
  • Arizona Cancer Center
  • University of Arkansas for Medical Sciences
  • Veterans Affairs Medical Center - Little Rock (McClellan)
  • City of Hope Comprehensive Cancer Center
  • Rebecca and John Moores UCSD Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Cedars-Sinai Medical Center
  • Veterans Affairs Medical Center - West Los Angeles
  • Jonsson Comprehensive Cancer Center, UCLA
  • Veterans Affairs Outpatient Clinic - Martinez
  • CCOP - Bay Area Tumor Institute
  • Chao Family Comprehensive Cancer Center
  • University of California Davis Cancer Center
  • Veterans Affairs Medical Center - San Diego
  • Veterans Affairs Medical Center - San Francisco
  • CCOP - Santa Rosa Memorial Hospital
  • David Grant Medical Center
  • University of Colorado Cancer Center
  • Veterans Affairs Medical Center - Denver
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center
  • MBCCOP - Howard University Cancer Center
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Washington, DC
  • Broward General Medical Center
  • Memorial Regional Hospital Comprehensive Cancer Center
  • CCOP - Mount Sinai Medical Center
  • Florida Hospital Cancer Institute
  • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
  • CCOP - Atlanta Regional
  • Dwight David Eisenhower Army Medical Center
  • Cancer Research Center of Hawaii
  • MBCCOP - Hawaii
  • Tripler Army Medical Center
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • MBCCOP - University of Illinois at Chicago
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • CCOP - Central Illinois
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • Loyola University Medical Center
  • West Suburban Center for Cancer Care
  • Saint Anthony Medical Center
  • Fort Wayne Medical Oncology and Hematology, Incorporated
  • CCOP - Northern Indiana CR Consortium
  • Hematology Oncology Associates of the Quad Cities
  • Holden Comprehensive Cancer Center
  • University of Kansas Medical Center
  • CCOP - Wichita
  • Veterans Affairs Medical Center - Wichita
  • Veterans Affairs Medical Center - Lexington
  • Albert B. Chandler Medical Center, University of Kentucky
  • Baptist Hospital East - Louisville
  • MBCCOP - LSU Health Sciences Center
  • Tulane University School of Medicine
  • Veterans Affairs Medical Center - New Orleans
  • Louisiana State University Health Sciences Center - Shreveport
  • Veterans Affairs Medical Center - Shreveport
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Veterans Affairs Medical Center - Baltimore
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Boston Medical Center
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • University of Massachusetts Memorial Medical Center - University Campus
  • Veterans Affairs Medical Center - Ann Arbor
  • CCOP - Michigan Cancer Research Consortium
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Detroit
  • Henry Ford Hospital
  • CCOP - Grand Rapids
  • CCOP - Beaumont
  • Lakeland Medical Center - St. Joseph
  • Providence Hospital - Southfield
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Veterans Affairs Medical Center - Biloxi
  • University of Mississippi Medical Center
  • Veterans Affairs Medical Center - Jackson
  • Keesler Medical Center - Keesler AFB
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
  • Ellis Fischel Cancer Center - Columbia
  • Veterans Affairs Medical Center - Kansas City
  • CCOP - Kansas City
  • Barnes-Jewish Hospital
  • St. Louis University Health Sciences Center
  • Missouri Baptist Cancer Center
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Montana Cancer Consortium
  • University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - Las Vegas
  • Norris Cotton Cancer Center
  • Cooper University Hospital
  • Veterans Affairs Medical Center - Albuquerque
  • MBCCOP - University of New Mexico HSC
  • Veterans Affairs Medical Center - Albany
  • Veterans Affairs Medical Center - Buffalo
  • Roswell Park Cancer Institute
  • Elmhurst Hospital Center
  • Queens Cancer Center of Queens Hospital
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Weill Medical College of Cornell University
  • Mount Sinai Medical Center, NY
  • Herbert Irving Comprehensive Cancer Center
  • James P. Wilmot Cancer Center
  • State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Veterans Affairs Medical Center - Asheville
  • Lineberger Comprehensive Cancer Center, UNC
  • NorthEast Oncology Associates
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • Cape Fear Valley Health System
  • Lenoir Memorial Hospital Cancer Center
  • FirstHealth Moore Regional Hospital
  • New Hanover Regional Medical Center
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • Veterans Affairs Medical Center - Fargo
  • Veterans Affairs Medical Center - Cincinnati
  • Barrett Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • Arthur G. James Cancer Hospital - Ohio State University
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • University of Oklahoma Health Sciences Center
  • Veterans Affairs Medical Center - Oklahoma City
  • Oregon Cancer Institute
  • Veterans Affairs Medical Center - Portland
  • CCOP - Columbia River Oncology Program
  • Western Pennsylvania Hospital
  • Lifespan: The Miriam Hospital
  • Veterans Affairs Medical Center - Charleston
  • Medical University of South Carolina
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • University of Tennessee Cancer Institute
  • Danville Radiation Therapy Center
  • Harrington Cancer Center
  • Veterans Affairs Medical Center - Amarillo
  • Veterans Affairs Medical Center - Dallas
  • Brooke Army Medical Center
  • University of Texas Medical Branch
  • University of Texas - MD Anderson Cancer Center
  • Veterans Affairs Medical Center - Houston
  • Texas Tech University Health Science Center
  • University of Texas Health Science Center at San Antonio
  • Veterans Affairs Medical Center - San Antonio (Murphy)
  • Veterans Affairs Medical Center - Temple
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute
  • Veterans Affairs Medical Center - Salt Lake City
  • Green Mountain Oncology Group
  • Vermont Cancer Center
  • Fletcher Allen Health Care - University Health Center Campus
  • Veterans Affairs Medical Center - White River Junction
  • Martha Jefferson Hospital
  • Virginia Oncology Associates - Norfolk
  • MBCCOP - Massey Cancer Center
  • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • CCOP - Virginia Mason Research Center
  • Veterans Affairs Medical Center - Seattle
  • CCOP - Northwest
  • Madigan Army Medical Center
  • St. Mary's Medical Center
  • Ministry Medical Group - Northern Region
  • British Columbia Cancer Agency
  • University of Puerto Rico School of Medicine Medical Sciences Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgery + leucovorin + fluorouracil + radiation

Arm Description

Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

Outcomes

Primary Outcome Measures

disease-free survival

Secondary Outcome Measures

overall survival
colostomy-free survival

Full Information

First Posted
September 13, 2001
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00023751
Brief Title
Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer
Official Title
A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer. PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.
Detailed Description
OBJECTIVES: Determine the overall, disease-free, and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy. Determine the local, regional, and distant recurrence rates in patients treated with these regimens. Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens. Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens. Determine the anorectal, urinary, and sexual function effects in patients treated with these regimens. Determine the non-functional treatment morbidity and mortality exclusive of anorectal, urinary, and sexual function effects in patients treated with these regimens. Determine the overall survival of patients with pathology exclusions undergoing local excision. Determine the efficacy of the current standard in detecting recurrence during follow-up, including office visits, blood tests, and proctoscopy in patients treated with these regimens. OUTLINE: This is a multicenter study. All patients undergo full thickness disc excision. Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage I rectal cancer, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgery + leucovorin + fluorouracil + radiation
Arm Type
Experimental
Arm Description
Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
Up to 5 years
Title
colostomy-free survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the rectum T1 or T2 by physical and endoscopic exams No T3 lesions by clinical or radiological exam Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer No multi-focal disease within the rectum at time of initial diagnosis No non-adenocarcinomatous rectal cancer or anal cancer Less than 4 cm at greatest diameter Less than 40% of rectal wall circumference involved Proximal margin no greater than 8 cm from dentate line No tumor fixation to the perirectal tissues regardless of size No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging No palpable perirectal lymph nodes or nodes larger than 1 cm No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.8 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins Prior incision or operative biopsy or colonoscopic removal allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Bleday, MD
Organizational Affiliation
Dana-Farber/Brigham and Women's Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
MBCCOP - Gulf Coast
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
CCOP - Greater Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Veterans Affairs Medical Center - Little Rock (McClellan)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Veterans Affairs Medical Center - West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Veterans Affairs Outpatient Clinic - Martinez
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Veterans Affairs Medical Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
David Grant Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MBCCOP - Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Veterans Affairs Medical Center - Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Memorial Regional Hospital Comprehensive Cancer Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
Dwight David Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905-5650
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813-2424
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859-5000
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-W227
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153-5500
Country
United States
Facility Name
West Suburban Center for Cancer Care
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Saint Anthony Medical Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61108
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Incorporated
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Hematology Oncology Associates of the Quad Cities
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7353
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
Veterans Affairs Medical Center - Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502-2236
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Baptist Hospital East - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Veterans Affairs Medical Center - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Veterans Affairs Medical Center - Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Veterans Affairs Medical Center - Boston (Jamaica Plain)
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Veterans Affairs Medical Center - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0912
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1932
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
Lakeland Medical Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Providence Hospital - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075-9975
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531-2410
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Veterans Affairs Medical Center - Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Keesler Medical Center - Keesler AFB
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Veterans Affairs Medical Center - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5138
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Veterans Affairs Medical Center - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Veterans Affairs Medical Center - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
NorthEast Oncology Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Valley Health System
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
Lenoir Memorial Hospital Cancer Center
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28503-1678
Country
United States
Facility Name
FirstHealth Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402-9025
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Veterans Affairs Medical Center - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
Veterans Affairs Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2288
Country
United States
Facility Name
Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0501
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-9001
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Veterans Affairs Medical Center - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Veterans Affairs Medical Center - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Danville Radiation Therapy Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Veterans Affairs Medical Center - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Veterans Affairs Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6200
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Veterans Affairs Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Science Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Veterans Affairs Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
Veterans Affairs Medical Center - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Green Mountain Oncology Group
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Veterans Affairs Medical Center - White River Junction
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
Martha Jefferson Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5000
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Ministry Medical Group - Northern Region
City
Rhinelander
State/Province
Wisconsin
ZIP/Postal Code
54501
Country
United States
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
University of Puerto Rico School of Medicine Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

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