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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 ID: NCT00114231
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, 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
Name: Julio Garcia-Aguilar, MD, PhD
Affiliation: City of Hope Comprehensive Cancer Center
Role: STUDY_CHAIR