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Spots Global Cancer Trial Database for Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.

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Trial Identification

Brief Title: Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.

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

Study ID: NCT00216008

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Contact Details

Name: Chris Garrett, MD

Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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