Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430027
Status:
TERMINATED
Last Update Posted:
2013-12-12
First Post:
2007-01-30
Brief Title:
Preoperative Capecitabine Oxaliplatin Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Pilot Feasibility Trial of Preoperative Capecitabine Oxaliplatin Cetuximab and Radiation Therapy for Locally Advanced Esophageal Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated due slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this pilot study is to determine whether neoadjuvant capecitabineoxaliplatincetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine oxaliplatin and cetuximab is feasible and tolerable
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None