PANCREATIC ADENOCARCINOMA' MedDRA version: 14.1 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GEMZAR*INFUS 1FL 1G POLV
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Gemcitabine
Concentration unit: % percent
Concentration number: 1-
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histological proven pancreatic ductal adenocarcinoma Patients who have supplied the written informed consent. Patients who have completed the staging of the disease Are the trial subjects under 18? no Number of subjects for this age range: 0 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: Cerebral metastases HIV infection or AIDS. Not agreement or withdrawal of the informed consent. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: verify the possibility that the rate of potentially curative surgical resection may increase in patients treated with neoadjuvant chemoradiotherapy plus surgery.;Secondary Objective: Safety and efficacy of neoadjuvant chemoradiotherapy;Primary end point(s): The end point of the study is that to verify the possibility that the rate of potentially curative surgical resection may increase in patients treated with neoadjuvant chemoradiotherapy plus surgery. | — |
Countries
Italy
Outcome results
None listed