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Spots Global Cancer Trial Database for Pre-op Rectal ChemoRad +/- Cetuximab

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Trial Identification

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

Conditions

Rectal Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Andrew D McCollum, MD

Affiliation: US Oncology Research

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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