Pilot Feasibility Trial of Preoperative Capecitabine, Oxaliplatin, Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal
cancer. This study proposes to evaluate the novel combination of preoperative capecitabine,
oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by
esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further
adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant
capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy
will be feasible and result in acceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.
Up to 4 weeks
Tracey Schefter, MD
University of Colorado at Denver and Health Science Center
United States: Food and Drug Administration
|University of Colorado at Denver and Health Science Center||Aurora, Colorado 80045|