Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
American College of Surgeons
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00114231
First received: June 13, 2005
Last updated: June 6, 2012
Last verified: December 2009
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Purpose
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: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of resectability as measured by the pathology report at surgery [ Designated as safety issue: No ]
- Procedure-specific morbidity and mortality rate as measured by NCI CTCAE one month after surgery [ Designated as safety issue: No ]
- Rate of pathologic complete response of the primary tumor as measured by RECIST at surgery [ Designated as safety issue: No ]
- Anorectal function and quality of life as measured by the fecal incontinence severity index, fecal incontinence quality of life questionnaire, and functional assessment of cancer therapy-colorectal questionnaire one year after surgery [ Designated as safety issue: No ]
- Feasibility of using molecular studies to assess surgical resection margins and tumor response as measured by ligation detection reaction-polymerase chain reaction after surgery [ Designated as safety issue: No ]
- Molecular markers associated with local tumor recurrence by several molecular techniques after completion of study treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 102 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed invasive adenocarcinoma of the rectum
T2, N0 (stage I) disease by endorectal ultrasound (ERUS) scan
- No T1, T3, or T4 disease
- No tumors fixed to adjacent structures by digital exam
- Greatest tumor diameter ≤ 4 cm
- Distal border of the tumor must be ≤ 8 cm from the anal verge by rigid proctoscopic exam
- No positive perirectal nodes by ERUS scan
- No histologic evidence of metastatic invasion of inguinal lymph nodes
- No metastatic or other primary disease by chest x-ray/CT scan, abdominal and pelvic CT scan/MRI with contrast, and colonoscopy
- No documented history of familial adenomatous polyposis
- No documented history of hereditary non-polyposis colorectal cancer diagnosed clinically or by genetic testing
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin > 9.5 mg/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST and ALT ≤ 2.0 times upper limit of normal (ULN)
- Bilirubin ≤ 3 mg/dL
- Alkaline phosphatase ≤ 2.0 times ULN
Renal
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No history of New York Heart Association class III-IV congestive heart failure
- No history of symptomatic coronary artery disease
- No history of uncontrolled arrhythmia
- No myocardial infarction within the past 6 months
- No history of any other clinically significant cardiac disease
Gastrointestinal
- No history of inflammatory bowel disease
- No history of difficulty or inability to take or absorb oral medications
Neurologic
- No clinically significant peripheral sensory or motor neuropathy
- No history of uncontrolled seizures or clinically significant central nervous system disorder
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy and/or hypersensitivity to capecitabine or oxaliplatin
- No other malignancy within the past 5 years except curatively treated nonmelanoma skin carcinoma or in situ carcinoma
- No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the pelvis
- No concurrent intensity modulated radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational drugs
- No other concurrent anticancer treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114231
Hide Study Locations
Hide Study LocationsLocations
| 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 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| 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 Cancer Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Allegheny Cancer Center at Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| UPMC - Shadyside | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| 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 | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| St. Clair Memorial Hospital Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15243 | |
| 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
American College of Surgeons
Investigators
| Study Chair: | Julio Garcia-Aguilar, MD, PhD | Beckman Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | David M. Ota, American College of Surgeons Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00114231 History of Changes |
| Other Study ID Numbers: | CDR0000433145, ACOSOG-Z6041 |
| Study First Received: | June 13, 2005 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the rectum stage I rectal cancer |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Colonic Diseases Oxaliplatin Capecitabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013