NCT06714604 Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
| NCT ID | NCT06714604 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Locally Advanced Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 432 participants |
| Start Date | 2023-10-18 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 432 participants in total. It began in 2023-10-18 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Elena Rangelova, PhD
PRINCIPAL INVESTIGATOR
Sahlgrenska University Hospital, Västra Götalandsregion
Frequently Asked Questions
Who can join the NCT06714604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Locally Advanced Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06714604 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 432 participants.
Is NCT06714604 currently recruiting?
Yes, NCT06714604 is actively recruiting participants. Contact the research team at elena.rangelova@gu.se for enrollment information.
Where is the NCT06714604 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06714604 clinical trial?
NCT06714604 is sponsored by Sahlgrenska University Hospital. The principal investigator is Elena Rangelova, PhD at Sahlgrenska University Hospital, Västra Götalandsregion. The trial plans to enroll 432 participants.