Preoperative Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
NCT00430027 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2013-12-12
Summary
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 and tolerable.
Conditions
- Esophageal Adenocarcinoma
Interventions
- DRUG
-
Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4
- DRUG
-
Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4
- DRUG
-
Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Tracey Schefter, MD · University of Colorado at Denver and Health Science Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2008-08-31
- Completion
- 2008-08-31
Countries
- United States
Study Locations
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