Standard Versus Prolonged Neoadjuvant (Conversion) Chemotherapy to Prolong Survival of Patients With Borderline and Locally Advanced Pancreatic Cancer: a Phase III Randomized Controlled

Trial ID: NCT06714604

Interventional - Phase 3 - Recruiting

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.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma
• Borderline Resectable Pancreatic Carcinoma
• Pancreas Cancer
• Neoadjuvant Chemotherapy
• Surgery
• Pancreatectomy

Interventions

• FOLFIRINOX or gemcitabine-nab-paclitaxel
• FOLFIRINOX or gemcitabine-nab-paclitaxel

Eligibility

Inclusion criteria

• 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

Exclusion criteria

• 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

Sponsor

Sahlgrenska University Hospital, Karolinska University Hospital

Source: ClinicalTrials.gov

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