Locally advanced pancreatic cancer. MedDRA version: 9.1 Level: LLT Classification code 10033611 Term: Pancreatic carcinoma non-resectable
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Age 18-75; - Zubrod Performance status 0-1; - Histologically confirmed locally advanced pancreatic cancer. 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: - Brain or visceral metastasis; - Prior radiotherapy or chemotherapy within 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall survival after 1 year of treatment with bevacizumab in combination with capecitabine and concomitant radiotherapy in patients affected by non-resectable locally advanced pancreatic cancer.;Secondary Objective: - To evaluate the incidence of serious adverse events during treatment; - To assess the objective response rate of this regimen; - To evaluate the failure free survival (FFS) after 1 year of treatment; - To assess the number of patient who undergo surgery after treament.;Primary end point(s): Overall survival. | — |
Countries
Italy