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

CONKO-Studiengruppe92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Max. 8 cycles of therapy

Secondary Outcomes

Secondary endpoint median survival, progression free survival and toxicity.

Time frame: 3 years