Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
Conditions
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
Interventions
DRUGAssociation of gemcitabine, oxaliplatin and radiotherapy
Sponsors
University Hospital, Ghent
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
| Tolerance | — |
Countries
Belgium
Outcome results
None listed