NCT00216008

Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (planned)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Adenocarcinomas
• Adenocarcinomas of the Gastroesophageal Junction

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	cisplatin
PROCEDURE	radiation
PROCEDURE	surgery

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-09-22
• Last updated: 2013-11-25

Locations

1 site across 1 country: United States