Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC
Recruiting
Phase 3
Interventional Study
Locally Advanced Pancreatic Adenocarcinoma
Borderline Resectable Pancreatic Carcinoma
Pancreas Cancer
Neoadjuvant Chemotherapy
Surgery
Pancreatectomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 432 (estimated)
- Sponsor
- Sahlgrenska University Hospital · Other
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About This Trial
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 …
Trial Locations
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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 A…
Contacts