Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216008
Status:
TERMINATED
Last Update Posted:
2013-11-25
First Post:
2005-09-19
Brief Title:
Pharmacogenomic Study of Docetaxel and Cisplatin Followed by Docetaxel Cisplatin and Irradiation
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Pharmacogenomic Study of Neoadjuvant Pre-irradiation Docetaxel and Cisplatin Followed by Neoadjuvant Concomitant Docetaxel Cisplatin and Irradiation Followed by Surgery CD-CDR-S in Adult Patients With Operable Adenocarcinomas of the Esophagus or Gastroesophageal Junction
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB Closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to find out the effectiveness of the experimental combination of Docetaxel Cisplatin and radiation therapy administered prior to the surgical removal of your esophageal cancer
Detailed Description:
This study seeks to determine the safety and efficacy the latter based on pathologic response rate three- and five-year survival rates of a three-phase multi-modality approach to adenocarcinomas of the esophagus or gastroesophageal junction This study also aims retrospectively to determine if a specific tumor gene array profile would predict for pathologic complete response Study schema is as follows Patients are first staged next they receive induction Docetaxel and Cisplatin on days 1 and 22 patients are then restaged next they will undergo radiation therapy combined with Cisplatin and Docetaxel for approximately days 42 thorough 84 patients are again restaged and finally surgery at approximately days 100 to 150
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 |
|---|---|---|---|
| IIT 14069 | None | None | None |
| USFIRB103493 | None | None | None |