IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Large Lung Tumors
|Recurrent Non-small Cell Lung Cancer||Radiation: Stereotactic body RT and IRGA||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum Tolerated Dose (MTD) [ Time Frame: 30 to 90 days ]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.
- Survival [ Time Frame: Up to 6 years ]Rates of local control, disease-free survival, and overall survival
- Biomarker testing [ Time Frame: 2 weeks ]Size of tissue samples sufficient for DNA analyses
- Pathological Response [ Time Frame: Up to 6 years ]Pathological response, changes in protein expression, and biomarker correlations with clinical outcome
- Quality of Life [ Time Frame: Up to 6 years ]Quality of life (European Organization for the Research and Treatment of Cancer [EORTC])
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||September 2018|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic Body RT and IRGA
Patients undergo stereotactic body radiation therapy QD for a total of 5 fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1 week later.
Radiation: Stereotactic body RT and IRGA
SABR Treatment with Dose escalation: Group 1: 40 Gy/5 fractions Group 2: 45 Gy/5 fractions Group 3: 50 Gy/5 fractions then IRGA procedure 1 week later with repeat lung biopsies, serum studies
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 week later.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746810
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Thomas Schroeder, MD||UNM Cancer Center|