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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286013
• Other study ID #: 2004/196
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2004
• Est. completion date: July 22, 2008

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 22, 2008
• Est. primary completion date: May 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Association of gemcitabine, oxaliplatin and radiotherapy

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels
Belgium	Jules Bordet Institute	Brussels
Belgium	University Hospital Ghent	Ghent
Belgium	CHU Sart-Tilman	Luik

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility
Primary	Tolerance

External Links

•   Website University Hospital Ghent