Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
NCT ID: NCT00114231
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2006-05-31
2014-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (capecitabine, oxaliplatin, radiotherapy, surgery)
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.
capecitabine
oxaliplatin
Given IV
neoadjuvant therapy
Undergo surgery
radiation therapy
Undergo radiotherapy
Interventions
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capecitabine
oxaliplatin
Given IV
neoadjuvant therapy
Undergo surgery
radiation therapy
Undergo radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Julio Garcia-Aguilar, MD, PhD
Role: STUDY_CHAIR
City of Hope Comprehensive Cancer Center
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, United States
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States
Reid Hospital & Health Care Services
Richmond, Indiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Integris Oncology Services
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, United States
UPMC - Moon
Moon Township, Pennsylvania, United States
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, United States
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States
St. Clair Memorial Hospital Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States
Washington Hospital Cancer Center
Washington, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
Surgical Oncology Associates
Newport News, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, United States
United Hospital Center
Clarksburg, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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ACOSOG-Z6041
Identifier Type: -
Identifier Source: secondary_id
CDR0000433145
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z6041
Identifier Type: -
Identifier Source: org_study_id
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