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Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer

NCT ID: NCT00759226

Last Updated: 2008-09-26

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2007-08-31

Brief Summary

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This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.

Detailed Description

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Conditions

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Esophageal Cancer

Keywords

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esophageal cancer Gemcitabine Cisplatin 5-FU Folinic Acid inoperable esophageal cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Gemcitabine 1000 mg/m2 (30 min)

Intervention Type DRUG

Cisplatin

Cisplatin 30 mg/m2 (90 min)

Intervention Type DRUG

5-FU

5-FU 750 mg/m2 (24h CI)

Intervention Type DRUG

Folinic Acid

Folinic Acid 200 mg/m2 (30 min)

Intervention Type DRUG

Other Intervention Names

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Gemzar Cisplatin medac 5-FU medac Rescuvolin

Eligibility Criteria

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Inclusion Criteria

* Age\>=18
* Histologically proven inoperable esophageal cancer
* Karnofsky Performance status \>=60%
* Estimated life expectancy of \> 12 weeks
* Measurable disease
* No other oncologic therapy
* Measurable disease
* Adequate bone marrow function
* Geographic proximity and compliance
* Informed consent
* Negative pregnancy test and adequate contraception

Exclusion Criteria

* Insufficient hepatic or renal function
* Elevated serum calcium
* Pregnancy/breast feeding
* Active infection
* Other malignancies
* Systemic tumour complications requiring emergency interventions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

medac GmbH

INDUSTRY

Sponsor Role collaborator

CONKO-Studiengruppe

OTHER

Sponsor Role lead

Responsible Party

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Charite Universitätsmedizin Berlin

Principal Investigators

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Hanno Riess, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite Universitätsmedizin Berlin

Locations

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Charite Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CONKO-101

Identifier Type: -

Identifier Source: org_study_id