Faculty, Staff and Student Publications
Publication Date
3-1-2024
Journal
Clinical Lung Cancer
Abstract
Introduction: Prior attempts to escalate radiation dose for non-small cell lung cancer (NSCLC) have not improved survival. Given the high risk for cardiopulmonary toxicity with treatment and heterogenous presentation of locally advanced NSCLC, it is unlikely that a single dose regimen is optimal for all patients. This phase I/II trial aims to evaluate a novel treatment approach where the level of accelerated hypofractionation is determined by the predicted toxicity from dose to organs at risk (OARs).
Methods: Patients ≥ 18 years old with lung cancer planned for fractionated radiotherapy to the lung with concurrent chemotherapy will be eligible. Radiation therapy (RT) will be delivered to a total dose of 60 to 66 Gy in 30, 25, or 20 fractions depending on the ability to meet constraints to key organs at risk including the lungs, heart, and esophagus. The primary endpoint is high grade pulmonary, esophageal, or cardiac toxicity. A Bayesian optimized design is used to determine stopping boundaries and evaluate the primary endpoint.
Conclusion: PACER will evaluate the safety and feasibility of personalized accelerated chemoradiotherapy for lung cancer.
Keywords
Humans, Adolescent, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Bayes Theorem, Chemoradiotherapy, Lung, Antineoplastic Combined Chemotherapy Protocols, Clinical Trials, Phase II as Topic, Clinical Trials, Phase I as Topic, Clinical trial, Dose escalation, Isotoxic radiation, Personalized medicine, Personalized radiation
DOI
10.1016/j.cllc.2023.11.004
PMID
38040540
PMCID
PMC11334968
PubMedCentral® Posted Date
3-1-2025
PubMedCentral® Full Text Version
Author MSS
Published Open-Access
yes
Included in
Bioinformatics Commons, Biomedical Informatics Commons, Genetic Phenomena Commons, Medical Genetics Commons, Oncology Commons