locally advanced adenocarcinoma of the exocrine pancreas not amenable to surgical resection. MedDRA version: 6.1 Level: PT Classification code 10052747
Conditions
Sponsors
ISTITUTO ONCOLOGICO ROMAGNOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Patients must have histologically or cytologically confirmed locally advanced adenocarcinoma of the exocrine pancreas not amenable to surgical resection because of vascular invasion or extensive lymph-node involvement. ·Patients must have measurable disease, according to RECIST criteria. ·Patients must be treatment-naïve ·Age >=18 years. ·Life expectancy greater than three months ·ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Participation in another clinical trial with any investigational agents within 30 days prior to study screening. ·Patients with distant metastases ·Untreated renal failure or hyperbilirubinemia ·Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. ·Pregnant or nursing patients because of the teratogenic effects of this combination. ·Cancer survivors can be included only if they have not been treated with abdominal radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to establish the safety (Maximum Tolerate Dose, MTD) of pemetrexed in combination with radiotherapy for locally advanced pancreatic cancer.;Secondary Objective: The secondary objectives are to evaluate the efficacy of this combination and to assess the role of PET/CT in the treatment planning and in the evaluation of response.;Primary end point(s): feasibility and safety | — |
Countries
Italy
Outcome results
None listed