Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 22, 2025
Date Accepted: Nov 25, 2025
Stereotactic Adaptive Radiation Therapy for Borderline Resectable/Locally Advanced Pancreatic Cancer to Minimize Gastrointestinal Toxicity (ARTIA-Pancreas): Protocol for a Single-Arm Prospective Trial
ABSTRACT
Background:
Computed tomography-guided stereotactic online adaptive radiotherapy (CT-STAR) allows for ablative radiation doses to be delivered to selected patients with borderline resectable/locally-advanced/unresectable pancreatic cancer (BR/LAPC). However, the use of CT-STAR to deliver ablative dose to the pancreas, while minimizing gastrointestinal side effects to reduce acute and late toxicity rates compared to historic controls, has yet to be prospectively evaluated.
Objective:
The primary objective of this prospective, single-arm, multi-center Phase II clinical trial (ARTIA-Pancreas) is to evaluate the rate of acute Grade 3+ gastrointestinal (GI) toxicity in BR/LAPC patients treated with ablatively-dosed CT-STAR compared to historical control.
Methods:
Patients with histologically or cytologically confirmed borderline-resectable, locally-advanced, or medically-inoperable pancreatic adenocarcinoma are eligible for participation. Consenting and eligible patients will be treated with CT-STAR delivering 5 fractions over 1-2 weeks with daily adaptation based on anatomic changes observed with onboard cone-beam computed tomography imaging. The primary endpoint of this trial is the of rate of acute patient-reported Grade 3+ treatment-related GI toxicities, assessed at 90 days post-CT-STAR and compared to a historical control rate of 20%. The key powered secondary endpoint is the rate of long-term patient-reported Grade 3+ treatment related GI toxicities, evaluated at 12 months post-CT-STAR and compared to a historical control rate of 25%. Additional secondary endpoints include overall survival, local (in-field) control rates, and distant-progression-free survival at 1- and 2-years post-CT-STAR.
Results:
Study completion is anticipated in February 2029, and the final study results will be published upon completion of the study.
Conclusions:
ARTIA-Pancreas represents the first prospective Phase II clinical trial to evaluate whether CT-STAR can reduce the rate of acute, patient-reported GI toxicities in patients with BR/LAPC compared to historical control. Findings from this clinical trial will provide evidence for safely and effectively incorporating ablatively-dosed adaptive radiotherapy into treatment regimens for this population. Clinical Trial: ClinicalTrials.gov NCT05764720
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