A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years
No
Julio Garcia-Aguilar, MD, PhD
Study Chair
Beckman Research Institute
United States: Federal Government
CDR0000433145
NCT00114231
May 2006
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
John Muir/Mt. Diablo Comprehensive Cancer Center | Walnut Creek, California 94598 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence Cancer Center at Holy Family Hospital | Spokane, Washington 99207 |
Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Praxair Cancer Center at Danbury Hospital | Danbury, Connecticut 06810 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Wayne Hospital | Greenville, Ohio 45331 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Methodist Hospital | Houston, Texas 77030 |
St. Vincent's Medical Center | Bridgeport, Connecticut 06606 |
UPMC Cancer Center at UPMC Presbyterian | Pittsburgh, Pennsylvania 15213 |
Tampa General Hospital | Tampa, Florida 33606 |
Integris Oncology Services | Oklahoma City, Oklahoma 73112 |
Cancer Care Center at John Muir Health - Concord Campus | Concord, California 94524-4110 |
UPMC Cancer Center at Beaver Medical Center | Beaver, Pennsylvania 15009 |
UPMC Cancer Center at Jefferson Regional Medical Center | Clairton, Pennsylvania 15025 |
UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
UPMC Cancer Center at the John P. Murtha Pavilion | Johnstown, Pennsylvania 15901 |
UPMC - Moon | Moon Township, Pennsylvania 15108 |
UPMC Cancer Center - Natrona Heights | Natrona Heights, Pennsylvania 15065 |
Jameson Memorial Hospital - North Campus | New Castle, Pennsylvania 16105 |
UPMC - Shadyside | Pittsburgh, Pennsylvania 15213-2582 |
UPMC Cancer Center at UPMC St. Margaret | Pittsburgh, Pennsylvania 15215 |
St. Clair Memorial Hospital Cancer Center | Pittsburgh, Pennsylvania 15243 |
UPMC Cancer Center at UPMC Passavant | Pittsburgh, Pennsylvania 15237 |
UPMC Cancer Center at UPMC Northwest | Seneca, Pennsylvania 16346 |
Washington Hospital Cancer Center | Washington, Pennsylvania 15301 |
United Hospital Center | Clarksburg, West Virginia 26301 |
Surgical Oncology Associates | Newport News, Virginia 23606 |