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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: June 13, 2005
Last updated: August 3, 2015
Last verified: August 2015

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.

Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: oxaliplatin
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of resectability as measured by the pathology report at surgery [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • morbidity and mortality rate [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
  • Rate of pathologic complete response of the primary tumor [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Local-failure-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: May 2006
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: capecitabine
Other Name: Given IV
Drug: oxaliplatin
Given IV
Procedure: neoadjuvant therapy
Undergo surgery
Other Name: therapeutic conventional surgery
Radiation: radiation therapy
Undergo radiotherapy
Other Name: irradiation, radiotherapy, therapy, radiation

Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00114231

  Hide Study Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Connecticut
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, North Dakota
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
CCOP - Dayton
Dayton, Ohio, United States, 45429
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Integris Oncology Services
Oklahoma City, Oklahoma, United States, 73112
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, United States, 15901
UPMC - Moon
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States, 16105
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States, 15213-2582
St. Clair Memorial Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Washington Hospital Cancer Center
Washington, Pennsylvania, United States, 15301
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Surgical Oncology Associates
Newport News, Virginia, United States, 23606
United States, Washington
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, United States, 99207
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, West Virginia
United Hospital Center
Clarksburg, West Virginia, United States, 26301
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Julio Garcia-Aguilar, MD, PhD Beckman Research Institute
  More Information

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00114231     History of Changes
Other Study ID Numbers: ACOSOG-Z6041, ACOSOG-Z6041, U10CA180821, U10CA076001, CDR0000433145
Study First Received: June 13, 2005
Last Updated: August 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the rectum
stage I rectal cancer

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015