Randomized, fase II-III study of peri and post surgery chemiotherapy in removable pancreas carcinoma - ND
- Conditions
- removable pancreas cancerMedDRA version: 9.1Level: LLTClassification code 10033614
- Registration Number
- EUCTR2010-019942-23-IT
- Lead Sponsor
- FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
cito-histologic diagnosis of pancreas adenocarcinoma; clinic level n. I-II;karnofsky > 60;age >18 and < 75 years old; convenient renal, epatic and midollar reserve
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
other ongoing clinical trials; pregnancy and breast-feeding; previous chemiotherapy or radiotherapy for pancreas cancer; previous or concomitant cancer in other part of body; other conditions detaing the partecipation to the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the rate of patients without events (progression,relapse,metastasis,dead)1 year after randomization;Secondary Objective: to evaluate the rate of objective and biological responses, the rate of complication in surgery removal, the rate of tolerability of the treatments;Primary end point(s): rate of patients without event at 1 year
- Secondary Outcome Measures
Name Time Method