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NOT YET RECRUITING
NCT07871461
PHASE2

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

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-10

Completion Date

2028-09

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Induction 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.

DRUG

Induction 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.

RADIATION

MR-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.

PROCEDURE

Surgical 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.

Locations (1)

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States