Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

This study has suspended participant recruitment.
(Study suspended because of safety reasons)
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
First received: February 1, 2006
Last updated: December 19, 2007
Last verified: December 2007
The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma

Condition Intervention Phase
Locally Advanced and Unresectable, But Non-Metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
Drug: Association of gemcitabine, oxaliplatin and radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Feasibility
  • Tolerance

Estimated Enrollment: 30
Study Start Date: May 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease
  • WHO performance status of 0 or 1
  • Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed
  • Maximum delay after surgery: 8 weeks
  • No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ
  • Adequate bon marrow reserve
  • No previous chemotherapy or radiotherapy
  • Expected survival > 6 months

Exclusion Criteria:

  • Active infection
  • Metastatic disease
  • Inadequate liver function after derivative surgery
  • Inadequate renal function
  • Pregnancy, breast feeding
  • Use of any other investigational agent in the month before enrollment
  • Patients with grade 2 or more neuropathy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00286013

Erasme University Hospital
Brussels, Belgium, 1000
Jules Bordet Institute
Brussels, Belgium, 1000
University Hospital Ghent
Ghent, Belgium, 9000
CHU Sart-Tilman
Luik, Belgium, 4000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Marc Peeters, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00286013     History of Changes
Other Study ID Numbers: 2004/196 
Study First Received: February 1, 2006
Last Updated: December 19, 2007
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016