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

NCT00759226 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2008-09-26

No results posted yet for this study

Summary

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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 (30 min)

DRUG

Cisplatin

Cisplatin 30 mg/m2 (90 min)

DRUG

5-FU

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

DRUG

Folinic Acid

Folinic Acid 200 mg/m2 (30 min)

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • medac GmbH

    collaborator INDUSTRY

  • CONKO-Studiengruppe

    lead OTHER

Principal Investigators

  • Hanno Riess, MD, PhD · Charite Universitätsmedizin Berlin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2005-07-31
Completion
2007-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00759226 on ClinicalTrials.gov