Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00857246
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2009-03-04
Brief Title:
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Neoadjuvant Therapy of Gastric Cancer With Irinotecan Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University
Detailed Description:
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer To this end this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University NYU The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction GEJ cancers The program includes 1 systemic combination of Irinotecan Cisplatin and Cetuximab used as an induction 2 followed by potentially curative gastrectomy or GEJ resection and 3 post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMS CA225112 | OTHER | Bristol-Myers Squibb | None |