Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer (CONKO-101)

CONKO-Studiengruppe

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: Folinic Acid; Drug: Cisplatin; Drug: 5-FU; Drug: Gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00759226

CONKO-101

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)