Back to resultsPhase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus
Primary Purpose
Esophageal Diseases
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Taxol, Cisplatin, 5-Fluorouracil, G-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Diseases focused on measuring Esophageal Diseases
Eligibility 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.
Sites / Locations
- Emory University Winship Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00208936
Brief Title
Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
January 1996 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
5. Study Description
Brief Summary
This study is designed pre-operative for patients with resectable, local-regional carcinoma of the esophagus.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Diseases
Keywords
Esophageal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Taxol, Cisplatin, 5-Fluorouracil, G-CSF
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fanucchi, MD
Organizational Affiliation
Emory University Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus
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