International journal of radiation oncology, biology, physics · 2026
Long-Term Analysis of One Versus Three Fractions of Stereotactic Body Radiation Therapy for Peripheral Stage I to II Non-Small Cell Lung Cancer: A Randomized, Multi-Institution, Phase 2 Trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Singh Anurag K, Farrugia Mark K, Stephans Kevin L, Bogart Jeffrey A, Yu Han, Groman Adrienne, Videtic Gregory M
Аннотация
PURPOSE: Stereotactic body radiation therapy is standard of care for inoperable early-stage non-small cell lung cancer. Here, we report the long-term outcomes of 30 Gy in 1 fraction (arm 1) versus 60 Gy in 3 fractions (arm 2).
METHODS AND MATERIALS: This was a multi-institutional randomized, phase 2, 2-arm clinical trial. Medically inoperable patients with peripheral clinical T1-T2/N0M0 disease were enrolled. All patients had biopsy-confirmed disease. Patients were stratified by performance status and randomized to arm 1 or arm 2. The primary endpoint was thoracic grade 3 or higher adverse events per the Common Terminology Criteria for Adverse Events. Secondary endpoints included freedom from local failure, freedom from distal failure, progression-free (PFS) and overall survival (OS).
RESULTS: Between September 2008 and April 2015, 98 patients were randomized. Median survival was 40.3 months. There were no new attributable adverse events within the additional follow-up period. There were no differences in time to local failure, time to distant failure, PFS, or OS (P = .14, .17, .98, and .78, respectively).
CONCLUSIONS: This randomized phase 2 study demonstrated that 30 Gy in 1 fraction was equivalent to 60 Gy in 3 fractions in terms of toxicity, local failure, distant failure, PFS, and OS.
METHODS AND MATERIALS: This was a multi-institutional randomized, phase 2, 2-arm clinical trial. Medically inoperable patients with peripheral clinical T1-T2/N0M0 disease were enrolled. All patients had biopsy-confirmed disease. Patients were stratified by performance status and randomized to arm 1 or arm 2. The primary endpoint was thoracic grade 3 or higher adverse events per the Common Terminology Criteria for Adverse Events. Secondary endpoints included freedom from local failure, freedom from distal failure, progression-free (PFS) and overall survival (OS).
RESULTS: Between September 2008 and April 2015, 98 patients were randomized. Median survival was 40.3 months. There were no new attributable adverse events within the additional follow-up period. There were no differences in time to local failure, time to distant failure, PFS, or OS (P = .14, .17, .98, and .78, respectively).
CONCLUSIONS: This randomized phase 2 study demonstrated that 30 Gy in 1 fraction was equivalent to 60 Gy in 3 fractions in terms of toxicity, local failure, distant failure, PFS, and OS.