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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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