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 个研究点目标入组 47 人开始时间: 2013年6月24日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”