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OpenTrials
Completed

NCT Number: NCT00286013

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

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Key information

Conditions

Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Erasme University Hospital, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Association of gemcitabine, oxaliplatin and radiotherapy

Drug

Primary outcomes

  1. Feasibility

  2. Tolerance

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Feb 2, 2006
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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