Multicentre, two-stage, phase 2 study of neoadjuvant FOLFIRINOX followed by chemo-IMRT in patients with locally advanced unresectable pancreatic cancer

Phase 1

• Conditions: ocally advanced unresectable pancreatic cancer; MedDRA version: 16.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002074-46-IT
• Lead Sponsor: Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1. To evaluate: <br>the rate of conversion to resectability <br>R0 resection rate<br>progression free survival <br>overall survival<br>2. To validate di predicitive ability of early metabolic tumor change measured by PET/CT<br>3. To evaluate the predicitve ability of early functional tumor response measured by abdomen-pelvis MRN with Gd-BT-DO3A<br>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<br>Toxicity: every week

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): rate of conversion to resectability<br>R0 resection rate <br>progression free survival <br>overall survival;Timepoint(s) of evaluation of this end point: rate of conversion to resectability: week 19<br>R0 resection rate: surgery (week 20) <br>progression free survival: after 8 and 18 weeks from study start and every 3 months later<br>overall survival: death