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

This study has been suspended.

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

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Oxaliplatin

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

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Cholangiocarcinoma
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Carcinoma
Oxaliplatin
Digestive System Diseases

Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009