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Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
This study has been suspended.
( Study suspended because of safety reasons )
First Received: February 1, 2006   Last Updated: December 19, 2007   History of Changes
Sponsored by: University Hospital, Ghent
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00286013
  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 II

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy
Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Feasibility
  • Tolerance

Estimated Enrollment: 30
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286013

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

Additional Information:
No publications provided

Study ID Numbers: 2004/196
Study First Received: February 1, 2006
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00286013     History of Changes
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:
Antimetabolites
Cholangiocarcinoma
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Immunosuppressive Agents
Antiviral Agents
Carcinoma
Oxaliplatin
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009