FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with locally advanced pancreatic cancer (LAPC). A Nordic phase II study.

Odense University Hospital0 个研究点目标入组 75 人开始时间: 2018年3月12日最近更新: 2021年1月18日

试验速览

暂无简介。

•LAPC (Karolinska Type B, C or D).
•Cytologically or histologically verified adenocarcinoma/carcinoma
•The patient is operable (i.e. no co-morbidity which can preclude anaesthesia or sur-gery).
•No sign of M1 disease.
•WHO performance status 0-1.
•Age = 18 years.
•Adequate hematological, renal, and hepatic function: WBC > 3.0 x 109/l, platelets > 100 x 109/l, creatinine <1.5 x UNL (Upper normal limit), bilirubin <3.0 x UNL, PP % 0,5 – 1,3, APTT < 1,5 x UNL
•Patients with obstruction of bile duct or gut must be drained before start of therapy.
•Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.
•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 35

•No prior radiotherapy to abdominal cavity.
•No pregnancy or breast-feeding. Fertile patients must use adequate contraceptives.
•No sign of other severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months).
•No prior chemotherapy for PC.
•No prior chemotherapy or other oncologic therapy within 12 months.
•No contraindications towards FOLFIRINOX.

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