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Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
oxaliplatin
neoadjuvant therapy
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 adenocarcinoma of the rectum, stage I rectal cancer

Eligibility Criteria

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

Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2 Patient must have histologically confirmed invasive adenocarcinoma of the rectum; Note: patients with rectal tumors suspicious for invasion also are eligible Distal border of the patient's tumor must be within 8 cm from the anal verge as measured on endoscopic exam Patients with tumors fixed to adjacent structures on digital exam are NOT eligible Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4 tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm Patients with positive perirectal nodes on ERUS examination are NOT eligible Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are NOT eligible Patients with the following conditions are NOT allowed on study: Metastatic disease or other primaries (patient must have had chest X-ray/computed tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a colonoscopy) Previously documented history of familial adenomatous polyposis Previously documented history of hereditary non-polyposis colorectal cancer diagnosed clinically (Amsterdam II criteria) or by genetic testing History of inflammatory bowel disease History of prior radiation treatments to pelvis Clinically significant peripheral sensory or motor neuropathy (defined as symptomatic weakness, paresthesia or sensory alteration described to be interfering with function, interfering with activities of daily living, disabling or life-threatening) History of any clinically significant cardiac disease (i.e., class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the last 6 months) History of uncontrolled seizures or clinically significant central nervous system disorders History of psychiatric conditions or diminished mental capacity that could compromise the giving of informed consent, or interfere with study compliance History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin History of difficulty or inability to take or absorb oral medications White blood cells (WBC) >= 3000/mm^3 Absolute neutrophil count (ANC) > 1,500/mm^3 Hemoglobin > 9.5 mg/dl Platelet count >= 100,000/mm^3 Total bilirubin =< 3 mg/dl Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 times institutional upper limit of normal (ULN) Alkaline phosphatase =< 2.0 times ULN Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation Patients who have experienced a prior malignancy must have received potentially curative therapy for that malignancy, and must be cancer-free for at least five years from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin carcinoma, or in-situ carcinomas) Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration

Sites / Locations

  • Mayo Clinic Scottsdale
  • Cancer Care Center at John Muir Health - Concord Campus
  • City of Hope Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • John Muir/Mt. Diablo Comprehensive Cancer Center
  • St. Vincent's Medical Center
  • Praxair Cancer Center at Danbury Hospital
  • Mayo Clinic - Jacksonville
  • Tampa General Hospital
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  • University of Chicago Cancer Research Center
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Indiana University Melvin and Bren Simon Cancer Center
  • William N. Wishard Memorial Hospital
  • Reid Hospital & Health Care Services
  • Ochsner Cancer Institute at Ochsner Clinic Foundation
  • Mayo Clinic Cancer Center
  • Altru Cancer Center at Altru Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Middletown Regional Hospital
  • Wayne Hospital
  • Charles F. Kettering Memorial Hospital
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Clinton Memorial Hospital
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Integris Oncology Services
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Providence Cancer Center at Providence Portland Medical Center
  • Knight Cancer Institute at Oregon Health and Science University
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • UPMC Cancer Center at Beaver Medical Center
  • UPMC Cancer Center at Jefferson Regional Medical Center
  • UPMC Cancer Center - Arnold Palmer Pavilion
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • UPMC Cancer Center at the John P. Murtha Pavilion
  • UPMC - Moon
  • UPMC Cancer Center - Natrona Heights
  • Jameson Memorial Hospital - North Campus
  • Fox Chase Cancer Center - Philadelphia
  • Allegheny Cancer Center at Allegheny General Hospital
  • UPMC - Shadyside
  • UPMC Cancer Center at Magee-Womens Hospital
  • UPMC Cancer Center at UPMC Presbyterian
  • UPMC Cancer Center at UPMC St. Margaret
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • UPMC Cancer Centers
  • UPMC Cancer Center at UPMC Passavant
  • St. Clair Memorial Hospital Cancer Center
  • UPMC Cancer Center at UPMC Northwest
  • Washington Hospital Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • M. D. Anderson Cancer Center at University of Texas
  • Methodist Hospital
  • Surgical Oncology Associates
  • Providence Cancer Center at Sacred Heart Medical Center
  • Providence Cancer Center at Holy Family Hospital
  • United Hospital Center
  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)

Arm Description

Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.

Outcomes

Primary Outcome Measures

3-Year Disease-free Survival
The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.

Secondary Outcome Measures

R0 Resection Rate (Negative Margin Rate)
The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
Morbidity and Mortality Rate
Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
Rate of Pathologic Complete Response of the Primary Tumor
The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.
Local Recurrence Rate
The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.

Full Information

First Posted
June 13, 2005
Last Updated
February 21, 2018
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00114231
Brief Title
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
Official Title
A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (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
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.
Detailed Description
OBJECTIVES: Primary Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and radiotherapy followed by local excision. Secondary Determine the rate of resectability with negative resection margins in patients treated with this regimen. Determine the procedure-specific morbidity and mortality in patients treated with this regimen. Determine the rate of pathologic complete response of the primary tumor in patients treated with this regimen. Determine the impact of this regimen on anorectal function and quality of life in these patients. Determine the feasibility of using molecular studies to assess surgical resection margins and tumor response in patients treated with this regimen. Determine molecular markers associated with local tumor recurrence in patients treated with this regimen. OUTLINE: This is a non-randomized, multicenter study. Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35 and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician. Quality of life is assessed at baseline and then 1 year after surgery. After completion of study treatment, patients are followed at 1 month, every 4 months for 3 years, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
Arm Type
Experimental
Arm Description
Patients undergo high-dose external beam radiotherapy once daily and receive capecitabine PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Given IV
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Other Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiotherapy
Primary Outcome Measure Information:
Title
3-Year Disease-free Survival
Description
The primary endpoint was 3-year disease-free survival (DFS). Evidence of local recurrence, distant metastasis, or death from any cause within 3 years counted as events in the time-to-event Kaplan-Meier analysis of disease-free survival.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
R0 Resection Rate (Negative Margin Rate)
Description
The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
Time Frame
At time of surgery
Title
Morbidity and Mortality Rate
Description
Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
Time Frame
Up to 30 days
Title
Rate of Pathologic Complete Response of the Primary Tumor
Description
The rate (percentage) of patients with pathologic complete response (pCR) is reported below. Pathologic response will be determined by comparing tumor width and stage in the surgical specimen with the same parameters as determined by pre-CRT ERUS: PATHOLOGIC COMPLETE RESPONSE (pCR): no residual tumor.
Time Frame
Up to 5 years
Title
Local Recurrence Rate
Description
The local recurrence rate (percentage) is defined as the percentage of patients who had local recurrence as initial sites of failure at the end of follow-up.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of =< 2 Patient must have histologically confirmed invasive adenocarcinoma of the rectum; Note: patients with rectal tumors suspicious for invasion also are eligible Distal border of the patient's tumor must be within 8 cm from the anal verge as measured on endoscopic exam Patients with tumors fixed to adjacent structures on digital exam are NOT eligible Patient must have an uT2uN0 tumor, as confirmed by endorectal ultrasound (ERUS) or endorectal coil magnetic resonance imaging (MRI) scan; patients with uT1, uT3, or uT4 tumors are NOT eligible; greatest diameter of tumor cannot exceed 4 cm Patients with positive perirectal nodes on ERUS examination are NOT eligible Patients with histologic evidence of metastatic invasion of inguinal lymph nodes are NOT eligible Patients with the following conditions are NOT allowed on study: Metastatic disease or other primaries (patient must have had chest X-ray/computed tomography [CT] and abdominal & pelvic CT/MRI with IV contrast, as well as a colonoscopy) Previously documented history of familial adenomatous polyposis Previously documented history of hereditary non-polyposis colorectal cancer diagnosed clinically (Amsterdam II criteria) or by genetic testing History of inflammatory bowel disease History of prior radiation treatments to pelvis Clinically significant peripheral sensory or motor neuropathy (defined as symptomatic weakness, paresthesia or sensory alteration described to be interfering with function, interfering with activities of daily living, disabling or life-threatening) History of any clinically significant cardiac disease (i.e., class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the last 6 months) History of uncontrolled seizures or clinically significant central nervous system disorders History of psychiatric conditions or diminished mental capacity that could compromise the giving of informed consent, or interfere with study compliance History of allergy and/or hypersensitivity to capecitabine and/or oxaliplatin History of difficulty or inability to take or absorb oral medications White blood cells (WBC) >= 3000/mm^3 Absolute neutrophil count (ANC) > 1,500/mm^3 Hemoglobin > 9.5 mg/dl Platelet count >= 100,000/mm^3 Total bilirubin =< 3 mg/dl Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 times institutional upper limit of normal (ULN) Alkaline phosphatase =< 2.0 times ULN Creatinine clearance (CLcr) >= 50 ml/min by Cockroft-Gault equation Patients who have experienced a prior malignancy must have received potentially curative therapy for that malignancy, and must be cancer-free for at least five years from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin carcinoma, or in-situ carcinomas) Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Garcia-Aguilar, MD, PhD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Cancer Care Center at John Muir Health - Concord Campus
City
Concord
State/Province
California
ZIP/Postal Code
94524-4110
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
John Muir/Mt. Diablo Comprehensive Cancer Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
St. Vincent's Medical Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Praxair Cancer Center at Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
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
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
William N. Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Ochsner Cancer Institute at Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Altru Cancer Center at Altru Hospital
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
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
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Integris Oncology Services
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
UPMC Cancer Center at Beaver Medical Center
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
UPMC Cancer Center at Jefferson Regional Medical Center
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
UPMC Cancer Center - Arnold Palmer Pavilion
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
UPMC Cancer Center at the John P. Murtha Pavilion
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
Facility Name
UPMC - Moon
City
Moon
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
Facility Name
UPMC Cancer Center - Natrona Heights
City
Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Facility Name
Jameson Memorial Hospital - North Campus
City
New Castle
State/Province
Pennsylvania
ZIP/Postal Code
16105
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Allegheny Cancer Center at Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC - Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
UPMC Cancer Center at Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Cancer Center at UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Cancer Center at UPMC St. Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1791
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Cancer Center at UPMC Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
St. Clair Memorial Hospital Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
UPMC Cancer Center at UPMC Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
Facility Name
Washington Hospital Cancer Center
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Surgical Oncology Associates
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Providence Cancer Center at Holy Family Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
United Hospital Center
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17103255
Citation
Ota DM, Nelson H; ACOSOG Group Co-Chairs. Local excision of rectal cancer revisited: ACOSOG protocol Z6041. Ann Surg Oncol. 2007 Feb;14(2):271. doi: 10.1245/s10434-006-9213-7. Epub 2006 Nov 14. No abstract available.
Results Reference
background
PubMed Identifier
21755378
Citation
Garcia-Aguilar J, Shi Q, Thomas CR Jr, Chan E, Cataldo P, Marcet J, Medich D, Pigazzi A, Oommen S, Posner MC. A phase II trial of neoadjuvant chemoradiation and local excision for T2N0 rectal cancer: preliminary results of the ACOSOG Z6041 trial. Ann Surg Oncol. 2012 Feb;19(2):384-91. doi: 10.1245/s10434-011-1933-7. Epub 2011 Jul 14.
Results Reference
result
PubMed Identifier
26474521
Citation
Garcia-Aguilar J, Renfro LA, Chow OS, Shi Q, Carrero XW, Lynn PB, Thomas CR Jr, Chan E, Cataldo PA, Marcet JE, Medich DS, Johnson CS, Oommen SC, Wolff BG, Pigazzi A, McNevin SM, Pons RK, Bleday R. Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial. Lancet Oncol. 2015 Nov;16(15):1537-1546. doi: 10.1016/S1470-2045(15)00215-6. Epub 2015 Oct 22.
Results Reference
result

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Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

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