IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Lung Tumors Larger Than 3 cm: Phase I Dose Escalation and Pilot Study With Companion Biomarker Analysis
This is a dose-escalation study of stereotactic body radiation therapy.
Patients undergo stereotactic body radiation therapy once daily (QD) for a total of 5
fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1
After completion of study treatment, patients are followed up at 4 weeks, every 3 months for
1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
The MTD will be defined as the highest dose level where less than or equal to 33% patients incurred a dose-limiting toxicity (DLT). A DLT will be defined as an acute (within 30 days) or subacute (31-90 days) irreversible grade 3 or any grade 4-5 toxicity (using National Cancer Institute [NCI]-Common Toxicity Criteria [CTC] version 4.0 criteria) that is possibly, probably, and definitely attributed to the therapy.
30 to 90 days
Thomas Schroeder, MD
UNM Cancer Center
United States: Institutional Review Board
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|