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

This study has been completed.
Eli Lilly and Company
medac GmbH
Information provided by:
CONKO-Studiengruppe Identifier:
First received: September 24, 2008
Last updated: September 25, 2008
Last verified: September 2008
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.

Condition Intervention Phase
Esophageal Cancer Drug: Gemcitabine Drug: Cisplatin Drug: 5-FU Drug: Folinic Acid Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by CONKO-Studiengruppe:

Primary Outcome Measures:
  • Primary endpoint rate of freedom of progression (PR+CR+SD). [ Time Frame: Max. 8 cycles of therapy ]

Secondary Outcome Measures:
  • Secondary endpoint median survival, progression free survival and toxicity. [ Time Frame: 3 years ]

Enrollment: 92
Study Start Date: July 2002
Study Completion Date: August 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine
    Gemcitabine 1000 mg/m2 (30 min)
    Other Name: Gemzar
    Drug: Cisplatin
    Cisplatin 30 mg/m2 (90 min)
    Other Name: Cisplatin medac
    Drug: 5-FU
    5-FU 750 mg/m2 (24h CI)
    Other Name: 5-FU medac
    Drug: Folinic Acid
    Folinic Acid 200 mg/m2 (30 min)
    Other Name: Rescuvolin

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00759226

Charite Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Eli Lilly and Company
medac GmbH
Principal Investigator: Hanno Riess, MD, PhD Charite Universitätsmedizin Berlin
  More Information

Responsible Party: Prof. Hanno Riess, Dr. Helmut Oettle, Charite Universitätsmedizin Berlin Identifier: NCT00759226     History of Changes
Other Study ID Numbers: CONKO-101
Study First Received: September 24, 2008
Last Updated: September 25, 2008

Keywords provided by CONKO-Studiengruppe:
esophageal cancer
Folinic Acid
inoperable esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Folic Acid
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Micronutrients processed this record on June 23, 2017