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Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus

This study has been terminated.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00208936
First received: September 13, 2005
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

This study is designed pre-operative for patients with resectable, local-regional carcinoma of the esophagus.


Condition Intervention Phase
Esophageal Diseases
 Drug: Taxol, Cisplatin, 5-Fluorouracil, G-CSF
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Pre-Operative Chemotherapy With Taxol, Cisplatin, and 5-Fluorouracil Followed by G-CSF in Patients With Resectable Local-Regional Carcinoma of Esophagus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Estimated Enrollment: 20
Study Start Date: January 1996
Detailed Description:

This study is designed for patients with resectable, local-regional carcinoma of the esophagus. In a pre-operative setting, chemotherapy with Taxol, Cisplatin, and 5-Fluorouracil will be administered followed by G-CSF.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable disease with resectable local-regional carcinoma of the esophagus. 18 years of age or older.

Exclusion Criteria:

  • Pregnant or lactating. Non-resectable local-regional carcinoma of the esophagus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208936

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Michael Fanucchi, MD Emory University Winship Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208936     History of Changes
Other Study ID Numbers: 0691-1995
Study First Received: September 13, 2005
Last Updated: December 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Esophageal Diseases

Additional relevant MeSH terms:
Carcinoma
Esophageal Diseases
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Cisplatin
Fluorouracil
Paclitaxel
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013