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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGWashington University, St. Louis
St Louis, Missouri, United States
RECRUITINGAcute Grade 3+ treatment related GI toxicities
The rate of acute Grade 3 or higher treatment related GI toxicities using CTCAE version 5.0 criteria
Time frame: Within 90 days from start of treatment
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
Time frame: 12 months after completion of external beam radiation treatment
Overall Survival
Kaplan-Meier estimates of the rates of overall survival
Time frame: One and two years after completion of external beam radiation treatment
Local in-field Control
Local (in-field) control rates defined as stable disease, partial response, or complete response by RECIST criteria
Time frame: One and two years after completion of external beam radiation treatment
Progression Free Survival
Kaplan-Meier estimates of distant-progression-free survival
Time frame: One and two years after completion of external beam radiation treatment
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UH Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITING