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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Julio Garcia-Aguilar, MD, PhD

Affiliation: City of Hope Comprehensive Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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