Status: Treatment Phase & Follow-up

A prospective randomized phase II trial of FOLFIRINOX alone versus FOLFIRINOX followed by radiochemotherapy in patients with locally advanced, primarily inoperable pancreatic cancer

Coordinating Investigators: Carmen Döller (Krems),
Gerald Prager (Vienna),
Martin Schindl (Vienna)
Start of study: 05/2017(national)
Sample size: 112
Sponsor: ABCSG

Description and status:

ABCSG P02 is the second pancreatic cancer related project initiated and conducted by ABCSG. Patients with locally advanced, primarily irresectable (irresectable and borderline irresectable) pancreatic cancer were enrolled into this Austrian-wide, academic research project. Primarily, this study was designed to demonstrate that within this patient collective, a neoadjuvant chemotherapy followed by concurrent radiochemotherapy is superior to neoadjuvant chemotherapy alone in terms of R0-resectability. Study start and “First Patient In” occurred on March 23rd, 2017 at study site “Ordensklinikum Linz – Elisabethinen”. Due to insufficient patient recruitment within the planned enrolment period, the ABCSG P02 investigator’s and ABCSG board decided in May 2022 to close study recruitment early. A total of 83 out of the 112 planned patients were enrolled into the study. It was decided that patient treatment and study follow-up will continue as planned per study protocol.

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