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

Phase 1

• Conditions: ocally advanced pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003775-62-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-12
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

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