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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
5-FU
Folinic Acid
Sponsored by
CONKO-Studiengruppe
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, Gemcitabine, Cisplatin, 5-FU, Folinic Acid, inoperable esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charite Universitätsmedizin Berlin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary endpoint median survival, progression free survival and toxicity.

Full Information

First Posted
September 24, 2008
Last Updated
September 25, 2008
Sponsor
CONKO-Studiengruppe
Collaborators
Eli Lilly and Company, medac GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00759226
Brief Title
Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer
Acronym
CONKO-101
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CONKO-Studiengruppe
Collaborators
Eli Lilly and Company, medac GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, Gemcitabine, Cisplatin, 5-FU, Folinic Acid, inoperable esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 1000 mg/m2 (30 min)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cisplatin medac
Intervention Description
Cisplatin 30 mg/m2 (90 min)
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
5-FU medac
Intervention Description
5-FU 750 mg/m2 (24h CI)
Intervention Type
Drug
Intervention Name(s)
Folinic Acid
Other Intervention Name(s)
Rescuvolin
Intervention Description
Folinic Acid 200 mg/m2 (30 min)
Primary Outcome Measure Information:
Title
Primary endpoint rate of freedom of progression (PR+CR+SD).
Time Frame
Max. 8 cycles of therapy
Secondary Outcome Measure Information:
Title
Secondary endpoint median survival, progression free survival and toxicity.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanno Riess, MD, PhD
Organizational Affiliation
Charite Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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