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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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00286013
First received: February 1, 2006
Last updated: December 19, 2007
Last verified: December 2007
History of Changes

February 1, 2006
December 19, 2007
May 2004
Not Provided
  • Feasibility
  • Tolerance
Same as current
Complete list of historical versions of study NCT00286013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

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
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced and Unresectable, But Non-Metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
Drug: Association of gemcitabine, oxaliplatin and radiotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
30
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00286013
2004/196
No
Not Provided
University Hospital, Ghent
Not Provided
Principal Investigator: Marc Peeters, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP