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

Information source: CONKO-Studiengruppe
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Esophageal Cancer

Intervention: Gemcitabine (Drug); Cisplatin (Drug); 5-FU (Drug); Folinic Acid (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: CONKO-Studiengruppe

Official(s) and/or principal investigator(s):
Hanno Riess, MD, PhD, Principal Investigator, Affiliation: Charite Universitätsmedizin Berlin

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.

Clinical Details

Official title: An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Primary endpoint rate of freedom of progression (PR+CR+SD).

Secondary outcome: Secondary endpoint median survival, progression free survival and toxicity.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Charite Universitätsmedizin Berlin, Berlin 13353, Germany
Additional Information

Starting date: July 2002
Last updated: September 25, 2008

Page last updated: August 20, 2015

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