LOCALLY ADVANCED PANCREATIC CANCER MedDRA version: 20.0 Level: PT Classification code 10001141 Term: Adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: FLUOROURACILE
CAS Number: 51-21-8
Current Sp
Sponsors
UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients that met the following inclusion criteria were included in the treatment protocol: proven cytological or histological diagnosis of PDAC; age between 18 and 75 years; no previous RCT; 0-I ECOG performance status; adequate cardiac, liver and kidney function and a good bone marrow reserve. Patients were included if they had borderline resectable or unresectable pancreatic tumours. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: The exclusion criteria were: resectable and metastatic disease; previous or concomitant malignant disease; one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2¿¿40 mmHg, mental disability.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EFFICACY (SURVIVAL AND RESPONSE RATE);Timepoint(s) of evaluation of this end point: 18 MONTHS | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: FEASIBILITY AND EFFICACY OF THE TREATMENT;Secondary Objective: SURVIVAL AND RESPONSE RATE;Primary end point(s): FEASIBILITY;Timepoint(s) of evaluation of this end point: 18 MONTHS | — |
Countries
Italy
Contacts
Public ContactU.O. DI RADIOTERAPIA
UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
Outcome results
None listed