Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00114231
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) capecitabine 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. Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) neoadjuvant therapy 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. Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) radiation therapy 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. Treatment (capecitabine, oxaliplatin, radiotherapy, surgery) oxaliplatin 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.
- Primary Outcome Measures
Name Time Method 3-Year Disease-free Survival Up to 3 years 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
Name Time Method R0 Resection Rate (Negative Margin Rate) At time of surgery The rate (percentage) of patients with negative resection margins after undergoing local excision is reported below.
Morbidity and Mortality Rate Up to 30 days Morbidity and mortality after neoadjuvant cheoradiotherapy and local excision.
Rate of Pathologic Complete Response of the Primary Tumor Up to 5 years 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 Up to 5 years 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.
Trial Locations
- Locations (67)
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, 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
UPMC Cancer Center at UPMC Passavant
🇺🇸Pittsburgh, Pennsylvania, United States
St. Clair Memorial Hospital Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
William N. Wishard Memorial Hospital
🇺🇸Indianapolis, Indiana, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
🇺🇸Savannah, Georgia, 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
Wayne Hospital
🇺🇸Greenville, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Cancer Care Center at John Muir Health - Concord Campus
🇺🇸Concord, California, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Praxair Cancer Center at Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Integris Oncology Services
🇺🇸Oklahoma City, Oklahoma, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
UPMC Cancer Center - Arnold Palmer Pavilion
🇺🇸Greensburg, Pennsylvania, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
UPMC Cancer Center at Beaver Medical Center
🇺🇸Beaver, Pennsylvania, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
UPMC Cancer Center at Jefferson Regional Medical Center
🇺🇸Clairton, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
UPMC - Moon
🇺🇸Moon, Pennsylvania, United States
UPMC Cancer Center - Natrona Heights
🇺🇸Natrona Heights, Pennsylvania, United States
Jameson Memorial Hospital - North Campus
🇺🇸New Castle, Pennsylvania, United States
UPMC Cancer Center at the John P. Murtha Pavilion
🇺🇸Johnstown, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC - Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Washington Hospital Cancer Center
🇺🇸Washington, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest
🇺🇸Seneca, Pennsylvania, United States
Surgical Oncology Associates
🇺🇸Newport News, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
United Hospital Center
🇺🇸Clarksburg, West Virginia, United States
Providence Cancer Center at Holy Family Hospital
🇺🇸Spokane, Washington, 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