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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286013
First Posted: February 2, 2006
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286013


Locations
Belgium
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
Investigators
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
First Submitted: February 1, 2006
First Posted: February 2, 2006
Last Update Posted: December 28, 2007
Last Verified: December 2007

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