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Clinical Trials in Sweden / NCT06714604
Recruiting Phase 3

Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC

NCT06714604 · tracked via the Priya Life Science Sweden tracker
Sponsor
Sahlgrenska University Hospital
Phase
Phase 3
Started
2023-10-18
Last updated
2024-12-03

Condition(s) studied

Locally Advanced Pancreatic AdenocarcinomaBorderline Resectable Pancreatic CarcinomaPancreas CancerNeoadjuvant ChemotherapySurgeryPancreatectomy

Investigational drug(s) / intervention(s)

FOLFIRINOX or gemcitabine-nab-paclitaxelAll Folfirinox trials (13) →All Gemcitabine-nab-paclitaxel trials (8) →FOLFIRINOX or gemcitabine-nab-paclitaxelAll Folfirinox trials (13) →All Gemcitabine-nab-paclitaxel trials (8) →

FOLFIRINOX or gemcitabine-nab-paclitaxel: 4 months if treatment

FOLFIRINOX or gemcitabine-nab-paclitaxel: 6 months of treatment

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall survival of all BR/LAPC patients — 24 months of randomization
    Comparison of overall survival of all enrolled BR/LAPC patients treated with the standard or the prolonged treatment
  • Overall survival of all resected BR/LAPC patients — 24 months of randomization
    Comparison of overall survival of the resected BR/LAPC patients treated with the standard or the prolonged treatment

Trial sites (1)

FacilityCityRegionStatus
SahlgrenskaUH Gothenburg VGR Recruiting

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CBT Treatment for Internet Gaming Disorder Starting soon
Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia Recruiting

Other trials for the same condition

Prognostic Factors in Periampullary Tumors and Cysts Recruiting
National Register Studies in Thoracic Surgery Active, not recruiting
Epidemiology of Perioperative Care in Sweden Active, not recruiting
Oncological Safety of Spleen Preservation in Left Pancreatectomy for Pancreatic Ductal Adenocarcinoma (SPLENDID) Active, not recruiting
Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06714604 on ClinicalTrials.gov ↗ ← All trials in Sweden