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

NCT ID: NCT00208936

Last Updated: 2014-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophageal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Taxol, Cisplatin, 5-Fluorouracil, G-CSF

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Nabil F. Saba

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Fanucchi, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

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Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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0691-1995

Identifier Type: -

Identifier Source: org_study_id

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