NeoWinner

Neoadjuvant MRI-guided online adaptive radiotherapy (oMRgRT) plus induction or consolidation chemotherapy in borderline resectable pancreatic cancer (BRPC) - NEOWINNER: a prospective, randomized, multicenter, pick-the-winner phase I trial of the AIO/ARO/ACO working groups

I

interventionell

National

Experimental intervention Arm A: MRI-guided online adaptive radiotherapy (5x6.68Gy, simultaneous integrated boost 5x8Gy) to the pancreatic cancer and adjacent vessels is performed every other day followed by 2 months (4 cycles) of preoperative treatment with mFOLFIRINOX (Oxaliplatin 85 mg/m² (d1), Irinotecan 150 mg/m² (d1), Leucovorin 400 mg/m², (D1), 5-FU 2.4 g/m² over 46 hours q2w) followed by tumor resection and 4 months (8 cycles) of postoperative treatment with mFOLFIRINOX Experimental intervention Arm B: 2 months (4 cycles) of preoperative treatment with mFOLFIRINOX (Oxaliplatin 85 mg/m² (d1), Irinotecan 150 mg/m² (d1), Leucovorin 400 mg/m², (D1), 5-FU 2.4 g/m² over 46 hours q2w) followed by the above defined MRI-guided online adaptive radiotherapy schedule (5x6.6/88Gy) followed by tumor resection and 4 months (8 cycles) of postoperative treatment with mFOLFIRINOX

Status: In Vorbereitung

Zeitraum

2026

2029

Zentren

6

Keine Zentren gesucht

Patienten

40

15.04.2025

Klinische Settings

I, II, IIA, IIB, IIC, III, IIIA, IIIB, IIIC

peri-operativ

kurativ

Beteiligte

AIO-Arbeitsgruppen

Sponsor

Universitätsklinikum Tübingen, ZKS

Kooperierende Fachgesellschaft(en)

Interdisziplinäre Arbeitsgruppe Viszeralonkologie – IAG VO
Assoziation Chirurgische Onkologie (ACO)
Arbeitsgemeinschaft Radiologische Onkologie (ARO)

Förderer

Geplant DFG

Identifier

AIO-PAK-0125/ass

Kontakt

Leitung

Prof. Dr. med. Thomas Seufferlein

Ansprechpartner*in

Dr. med. Thomas Ettrich
Telefon +49 731 50044774
E-Mail thomas.ettrich@uniklinik-ulm.de