Locally advanced unresectable pancreatic cancer MedDRA version: 16.0 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864
Conditions
Sponsors
Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione “G.Pascale”
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed locally advanced unresectable pancreatic adenocarcinoma - Unresectable stage III according to NCCN criteria - Age = 18 and = 70 years - At least one lesion measurable according to RECIST - PS ECOG 0-1 - Adequate bone marrow, liver and renal function - Patients who underwent endoscopic biliary drainage, with self-expandable metallic stent placement, are allowed, provided they have performed appropriate antibiotic prophylaxis and do not show significant alterations of laboratory tests as previously specified - Life expectancy of = 3 months - Signed written informed 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: - Metastatic disease - Previous chemotherapy or radiotherapy for pancreatic cancer - Previous or concurrent malignancy - Active acute or chronic systemic infections - Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 18 months - Cerebrovascular disease - Active venous or arterial thromboembolism - Severe respiratory disease - Chronic inflammatory bowel disease - Known HIV infection - Acute or Chronic HCV or HBV hepatitis - Peripheral neuropaty - Chronic liver or renal failure - Any systemic disease which in the opinion of the investigator would not permit the patient to undergo study treatment - Major surgery within 28 days from study start - Minor surgery (except CVC psitioning) within 14 days before treatment - Pregnancy or breastfeeding - Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate: the rate of conversion to resectability R0 resection rate progression free survival overall survival 2. To validate di predicitive ability of early metabolic tumor change measured by PET/CT 3. To evaluate the predicitve ability of early functional tumor response measured by abdomen-pelvis MRN with Gd-BT-DO3A 4. To validate the prognostic value of the CXCR4-CXCL12 pathway;Main Objective: To evaluate activity (in terms of objective response rate ) and toxcity, of neoadjuvant FOLFIRINOX followed by chemo-IMRT in patients wit locally advanced unresectable pancreatic cancer;Primary end point(s): objective response rate and unacceptable toxicity rate;Timepoint(s) of evaluation of this end point: Objective response raste:after 8 and 18 weeks from study start Toxicity: every week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): rate of conversion to resectability R0 resection rate progression free survival overall survival;Timepoint(s) of evaluation of this end point: rate of conversion to resectability: week 19 R0 resection rate: surgery (week 20) progression free survival: after 8 and 18 weeks from study start and every 3 months later overall survival: death | — |
Countries
Italy
Contacts
Public ContactUnità Sperimentazioni Cliniche
Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione “G.Pascale”
Outcome results
None listed