EUCTR2013-002074-46-IT
Active, Not Recruiting
Phase 1
Multicentre, two-stage, phase 2 study of neoadjuvant FOLFIRINOX followed by chemo-IMRT in patients with locally advanced unresectable pancreatic cancer - FolfIrinOx in NeoAdiuvant setting
Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”0 sites47 target enrollmentJune 24, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocally advanced unresectable pancreatic cancer
- Sponsor
- Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”
- Enrollment
- 47
- Status
- Active, Not Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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