Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Ghent

Conditions:

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

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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, oxalipl...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 22 2008

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00286013

Start Date

May 1 2004

End Date

July 22 2008

Last Update

December 9 2022

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Erasme University Hospital

Brussels, Belgium, 1000

2

Jules Bordet Institute

Brussels, Belgium, 1000

3

University Hospital Ghent

Ghent, Belgium, 9000

4

CHU Sart-Tilman

Liège, Belgium, 4000