Locally advanced pancreatic cancer MedDRA version: 6.1 Level: HLT Classification code 10033633
Conditions
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically/cytologically proven adenocarcinoma of the pancreas - Locally advanced, non resectable, non metastatic disease - Uni-dimensionally measurable disease - No previous chemo or radiotherapy - ECOG Performance Status PS 2 and Karnofsky index 60 Appendix I - Age between 18 and 75 years old - Life expectancy 12 weeks - No known CNS metastases - Neutrophils 1500/mm3 - Platelets 100 000/mm3 - Alkaline phosphatase 5 x Upper Normal Limit UNL and Bilirubin 1.5 x UNL jaundice present at diagnosis must be controlled by either biliary stenting or percutaneous drainage before treatment start - Creatinine 1.5 x UNL - No sensory neuropathy at inclusion - Pain and jaundice controlled before inclusion - Signed, written informed consent - Pain control by well conducted antalgic treatments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or breast feeding women - Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia - Uncontrolled or persistant hypercalcemia - History of significant neurologic or psychiatric disorders - Vater ampulomas and biliary tract adenocarcinomas - Other non cured- malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of the combination gemoxa followed by gem-rt;Secondary Objective: - Toxicity - Progression free survival - Overall survival - Resectability - Clinical benefit - Quality of life;Primary end point(s): Response rate | — |
Countries
Italy
Outcome results
None listed