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Brief Title: Pre-op Rectal ChemoRad +/- Cetuximab
Official Title: A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum
Study ID: NCT00527111
Brief Summary: The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.
Detailed Description: Rectal cancer remains a significant cause of morbidity and mortality in the United States. Standard treatment for patients with locally advanced rectal cancer generally includes combined chemotherapy and radiotherapy administered either before (neoadjuvant) or after (adjuvant) definitive surgical resection. Published data from Germany has suggested advantages to a neoadjuvant strategy. Currently, the standard concurrent chemoradiotherapy regimen in the United States is pelvic irradiation administered concurrently with 5-fluorouracil (5-FU) given as a protracted venous infusion. However, local recurrence remains a problem. Recently completed randomized trials of chemoradiotherapy have demonstrated local recurrence rates between 8-17% even with currently accepted standard chemoradiotherapy and adequate surgical management. Several recent trials have explored the use of radiotherapy and cetuximab with good results. Because of the non-overlapping toxicity profiles and the potentially diverse and complimentary mechanisms of action, the combination of chemotherapy plus ERBITUX given concurrently with pelvic radiotherapy may improve on the outcomes seen with current standards for patients with locally advanced adenocarcinoma of the rectum.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Oncology Associates D.B.A. Hematology Oncology Physicians & Extenders, Tucson, Arizona, United States
Melbourne Internal Medicine Associates, Melbourne, Florida, United States
Advanced Medical Specialties, Miami, Florida, United States
Cancer Centers of Florida, P.A., Ocoee, Florida, United States
Cancer Care & Hematology Specialists of Chicagoland, PC, Niles, Illinois, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Kansas City Cancer Centers-Southwest, Overland Park, Kansas, United States
Alliance Hematology Oncology PA, Westminster, Maryland, United States
Missouri Cance Associates, Columbia, Missouri, United States
St. Joseph Oncology, Inc., St. Joseph, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Cancer Centers of North Carolina, Raleigh, North Carolina, United States
Willamette Valley Cancer Center, Eugene, Oregon, United States
Texas Oncology - Amarillo, Amarillo, Texas, United States
Texas Oncology Cance Center, Austin, Texas, United States
Mamie McFaddin Ward Cancer Center, Beaumont, Texas, United States
Texas Cancer Center at Medical City, Dallas, Texas, United States
Methodist Charlton Cancer Ctr., Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
Texas Cancer Center, Denton, Texas, United States
El Paso Cancer Treatment Ctr, El Paso, Texas, United States
Texas Oncology, P.A., Fort Worth, Texas, United States
Lake Vista Cancer Center, Lewisville, Texas, United States
Longview Cance Center, Longview, Texas, United States
Allison Cancer Center, Midland, Texas, United States
Texas Oncology-Odessa, Odessa, Texas, United States
Paris Regional Cancer Center, Paris, Texas, United States
HOAST - Medical Dr., San Antonio, Texas, United States
Texas Cancer Center - Sherman, Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land, Sugar Land, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Texas Oncology Cancer Care and Research, Waco, Texas, United States
Texas Oncology, P.A., Webster, Texas, United States
Texoma Cancer Center, Wichita Falls, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Highline Medical Oncology, Burien, Washington, United States
Cancer Care Northwest-South, Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver, Vancouver, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge, Yakima, Washington, United States
Raleigh Regional Cancer Center, Beckley, West Virginia, United States
Name: Andrew D McCollum, MD
Affiliation: US Oncology Research
Role: PRINCIPAL_INVESTIGATOR