Induction Chemotherapy with Gemcitabine-Oxaliplatin GEM-OXA followed by concomitant weekly Gemcitabine plus Radiotherapy GEM/RT in Locally Advanced, Unresectable Pancreatic Cancer A Phase II Study - gemoxa followed by gem-rt

• Conditions: ocally advanced pancreatic cancer; MedDRA version: 6.1Level: HLTClassification code 10033633

• Registration Number: EUCTR2005-005063-29-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 56

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified