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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:
ClinicalTrials.gov Identifier:
NCT00208936
First Posted: September 21, 2005
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nabil F. Saba, Emory University
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Nabil F. Saba, Emory University:

Estimated Enrollment: 20
Study Start Date: January 1996
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nabil F. Saba, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00208936     History of Changes
Other Study ID Numbers: 0691-1995
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Nabil F. Saba, Emory University:
Esophageal Diseases

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Cisplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs