Rectal Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum
The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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