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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Max. 8 cycles of therapy

Safety Issue:

No

Principal Investigator

Hanno Riess, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite Universitätsmedizin Berlin

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CONKO-101

NCT ID:

NCT00759226

Start Date:

July 2002

Completion Date:

August 2007

Related Keywords:

  • Esophageal Cancer
  • esophageal cancer
  • Gemcitabine
  • Cisplatin
  • 5-FU
  • Folinic Acid
  • inoperable esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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