Utilizing Standard of Care Induction Chemotherapy Followed by MR-LINAC Radiotherapy and Surgical Exploration to Improve Resectability Rates in Potentially Resectable Locally Advanced Pancreatic Cancer
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Summary
Locally advanced pancreatic cancer (LAPC) is a high-mortality condition. This single-institution, Phase II, single-arm investigator-initiated trial at Allegheny Health Network investigates the optimal timing and integration of established standard-of-care interventions for biopsy-proven LAPC. Eligible participants will receive standard 4 months of induction chemotherapy, followed by standard MR-LINAC-guided radiotherapy, and subsequent surgical exploration with curative intent where feasible. The research question specifically pertains to the efficacy and safety of this predefined treatment sequence, aiming to increase the proportion of LAPC patients who achieve R0 resection and to translate local control gains into better survival and quality of life. The study plans to accrue approximately 18-20 patients.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients age 18 or older. 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. 3. Locally advanced, potentially resectable disease per ABC criteria after multidisciplinary review: 1. Anatomic: Tumor-artery contact \>180° but \<270° with the SMA or celiac, or ≤180° with mild contour irregularity but no frank stenosis; common hepatic artery (CHA) contact not reaching the celiac axis; venous involvement with a reconstructable SMV-PV segment. 2. Biologic: CA19-9 \< 600 U/mL (after biliary drainage if obstructed) and no evidenc…
Interventions
- DrugInduction Chemotherapy - FOLFIRINOX
Participants will receive approximately 4 months of systemic chemotherapy to treat micrometastatic disease and potentially downstage the tumor. The specific regimen will be either FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel, chosen by the investigator according to NCCN guidelines and institutional standards. This phase aims to optimize tumor biology prior to local consolidation therapy and subsequent surgery.
- DrugInduction Chemotherapy - Gemcitabine and Nab-Paclitaxel
Participants will receive approximately 4 months of systemic chemotherapy to treat micrometastatic disease and potentially downstage the tumor. The specific regimen will be either FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel, chosen by the investigator according to NCCN guidelines and institutional standards. This phase aims to optimize tumor biology prior to local consolidation therapy and subsequent surgery.
- RadiationMR-LINAC Guided Radiotherapy
Following induction chemotherapy, eligible participants will undergo hypofractionated radiotherapy utilizing an MR-LINAC (Magnetic Resonance-Linear Accelerator) system. This advanced image-guided radiation therapy allows for daily adaptive planning and real-time soft-tissue visualization to precisely target the pancreatic tumor while minimizing radiation exposure to surrounding healthy organs. This intervention serves as local consolidation therapy to improve local control and increase the likelihood of successful surgical resection.
- ProcedureSurgical Exploration and Resection
Approximately 4-8 weeks after completing MR-LINAC guided radiotherapy, participants will undergo surgical exploration with curative intent. The primary goal is to achieve a margin-negative (R0) resection of the pancreatic tumor, which is a key predictor of long-term survival. This may involve complex procedures such as venous resection/reconstruction and arterial divestment if deemed feasible and beneficial by the surgeon, following institutional standards and risk-benefit assessment.
Location
- AHN Allegheny General HospitalPittsburgh, Pennsylvania