The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.
Age ≥ 18 years of age.
Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site.
Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.
Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression.
Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.
Single group
Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)
RadiationRadiation Therapy Prescription Dose: A dose of 40-50 Gy in 5 fractions prescribed to the PTV will be used for all cases
Efficacy- Survivability and response
Rates of overall response will be assessed by RECIST criteria.Efficacy will be compared between PULSAR and historical controls from HILUS using ANOVA and chi-square test. Kaplan-Meier methods will be used to estimate progression-free survival, time to subsequent SABR, overall survival, clinical benefit rate, time to treatment discontinuation, duration of response, and time to new metastases. Response duration will be summarized for patients who responded. Descriptive summary statistics such as median and interquartile range (25% and 75% percentiles) will be used.
Change in Tumor Volume
Change in tumor volume will be measured by comparing pre-treatment tumor volume to during-treatment tumor volumes as measured by MRI and will be analyzed using an independent t-test.
Dosimetry
Dosimetry will be compared for relevant OARs, including heart, esophagus, and lung, and will be analyzed using an independent t-test.
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University of Texas Southwestern Medical Center
Lead sponsor
Elekta Limited
Collaborator
