Spots Global Cancer Trial Database for Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum

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Trial Identification

Brief Title: Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum

Official Title: A Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of the Rectum

Study ID: NCT00580073

Conditions

Rectal Cancer

Interventions

FOLFOX4

Cetuximab

Study Description

Brief Summary: This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery depending on your response to the treatment. Their use in this exact combination is considered experimental. The purpose of this study is to find out how effective this combination of chemotherapy is as treatment for rectal cancer that has not spread to other parts of the body. The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.

Detailed Description: Primary Objective: - Down-staging of the tumor Secondary Objectives: * Pathologic response rate * Tumor marker response * Incidence of sphincter sparing surgery * Progression-free survival * Overall Survival