Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

Recruiting now · Phase 3

Conditions studied: Locally Advanced Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Carcinoma, Pancreas Cancer, Neoadjuvant Chemotherapy, Surgery, Pancreatectomy

In brief

The goal of this multicenter randomized controlled phase III trial is to compare two durations of neoadjuvant chemotherapy (NAT) with mFOLFIRINOX or gemcitabine-nab-paclitaxel (GnP) before attempt for surgical resection in patients with borderline (BR) and locally advanced pancreatic cancer (LAPC). Patients with histologically confirmed non-metastatic BR/LAPC evaluated to potentially tolerate any of the treatment regimens and pancreatic surgery will be randomized to receive either standard duration NAT with 6 cycles mFOLFIRINOX or 4 cycles GnP or prolonged duration NAT with either 12 cycles mFOLFIRINOX or 6 cycles GnP before attempt for surgical resection, provided there is no evidence of disease progression. The primary objective is to compare the overall survival at 24 months after randomization of all treated patients and among the resected patients with BR/LAPC.

Key facts

Study ID

NCT06714604

Run by

Sahlgrenska University Hospital

People needed

432

Starts

2023-10-18

Expected to finish

2033-12-31

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, version 1.2022
• Histo- or cytologically confirmed adenocarcinoma (preferably EUS-guided)
• T1-4, Nx, M0 according to AJCC 8th edition
• ECOG 0-1 and considered fit for the planned chemotherapy at the local hospital and surgery at the two national centers for BR/LAPC
• Written informed patient consent

You may not qualify if…

• Co-morbidity precluding pancreatic surgery or chemotherapy
• Contraindications to any of the drugs in the proposed treatment regimens
• ECOG ≥2
• Neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6
• Granulocyte count < 1500 per cubic millimetre (< 1,5 x 109/L)
• Platelet count < 100 000 per cubic millimetre (< 100 x 109/L)
• Serum creatinine > 1.5 UNL (upper limit normal range)
• Albumin <2,5 g/dl (<25 g/L)
• Total bilirubin >3 x ULN
• ASAT (SGOT) and ALAT (SGPT) >2.5 x institutional ULN
• female patients in child-bearing age not using adequate contraception, pregnant or lactating women
• mental or somatic disorders which could possibly interfere with informed consent, compliance or the planned treatments
• previous oncologic treatment for PC within the past 5 years
• participation in other clinical trial with an investigational product during the past 30 days
• Any reason according to the investigator why the patient cannot comply with the protocol or is not suitable to participate

Where it is running

• SahlgrenskaUH — Gothenburg, VGR, Sweden (enrolling)

Full record on ClinicalTrials.gov

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