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

Phase 2

Completed

• Conditions: Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma

• Registration Number: NCT00286013
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05-01
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Primary Completion: 2006-05-31
• Study Completion: 2008-07-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility
Tolerance

Trial Locations

Locations (4)

CHU Sart-Tilman; 🇧🇪 Luik, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Jules Bordet Institute; 🇧🇪 Brussels, Belgium

Erasme University Hospital; 🇧🇪 Brussels, Belgium