Phase II Study of Pre-Operative Chemotherapy in Patients... | NCT00208936

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

NCT00208936

Sponsor

Emory University

Status

Terminated

Last Update Posted

Sep 9, 2014Estimated

Enrollment

Phase

Phase 2

Conditions

Esophageal Diseases

Interventions

Taxol, Cisplatin, 5-Fluorouracil, G-CSF

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1996

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2014

Last Update Posted Date

Sep 9, 2014Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Taxol, Cisplatin, 5-Fluorouracil, G-CSF	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Fanucchi, MD	Emory University Winship Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Winship Cancer Institute		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D004935	Esophageal Diseases

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel
D002945	Cisplatin
D005472	Fluorouracil
D016179	Granulocyte Colony-Stimulating Factor

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided