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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00759226

Acronym

CONKO-101

Enrollment

Registered

2008-09-25

Start date

2002-07-31

Completion date

2007-08-31

Last updated

2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

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

Brief 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.

Interventions

DRUGGemcitabine

Gemcitabine 1000 mg/m2 (30 min)

DRUGCisplatin

Cisplatin 30 mg/m2 (90 min)

DRUG5-FU

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

DRUGFolinic Acid

Folinic Acid 200 mg/m2 (30 min)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint rate of freedom of progression (PR+CR+SD).	Max. 8 cycles of therapy

Secondary

Measure	Time frame
Secondary endpoint median survival, progression free survival and toxicity.	3 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026