This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that stereotactic adaptive radiotherapy using an ablatively dosed (50Gy,5fx) for treatment of borderline-resectable, locally-advanced , or medically inoperable pancreatic adenocarcinoma will translate into a decreased toxicity. The study will evaluate GI toxicity, overall survival, local control, quality of life, and workflow metrics.
Histologically or cytologically confirmed borderline-resectable (based on NCCN criteria), locally-advanced (based on NCCN criteria), or medically inoperable pancreatic adenocarcinoma.
ECOG performance status 0-1
Receipt of at least two months of lead-in chemotherapy (regimen at the discretion of the treating physician) prior to planned initiation of CT-STAR.
Limited regional lymphadenopathy permitted. Node positive patients are restricted to those with up to 3 clinically involved (greater than 1cm on cross-sectional imaging or pathologically proven) nodes provided that the lymph nodes are adjacent to the primary tumor.
Past history of radiotherapy within the projected treatment field
Prior, intercurrent, or planned receipt (within 90 days prior to or following SBRT) of any investigational agents related to pancreatic cancer diagnosis.
Competing, active cancer diagnosis within the preceding one year.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Single group
Daily Adaptive External Beam Radiation Therapy
RadiationDaily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Acute Grade 3+ treatment related GI toxicities
The rate of acute Grade 3 or higher treatment related GI toxicities using CTCAE version 5.0 criteria
Long Term Grade 3+ treatment related GI toxicities
The rate of long term Grade 3 or higher treatment related GI toxicities, using CTCAE version 5.0 criteria
Overall Survival
Kaplan-Meier estimates of the rates of overall survival
Local in-field Control
Local (in-field) control rates defined as stable disease, partial response, or complete response by RECIST criteria
Progression Free Survival
Kaplan-Meier estimates of distant-progression-free survival
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Varian, a Siemens Healthineers Company
Lead sponsor
Washington University School of Medicine
Collaborator
