医学
随机对照试验
放射治疗
肺癌
临床试验
放射外科
人口
危险系数
剂量分馏
随机化
肿瘤科
放射科
核医学
内科学
置信区间
环境卫生
作者
Anand Swaminath,Marcin Wierzbicki,Sameer Parpia,James R. Wright,Theodoros Tsakiridis,Gordon Okawara,Vijayananda Kundapur,Alexis Bujold,Naseer Ahmed,Khalid Hirmiz,Elizabeth Kurien,Édith Filion,Zsolt Gabos,Sergio Faria,Alexander V. Louie,Timothy Owen,Elaine S. Wai,Kevin Ramchandar,Elisa Chan,Jim A. Julian,Kathryn Cline,Timothy J. Whelan
标识
DOI:10.1016/j.cllc.2016.08.002
摘要
We describe a Canadian phase III randomized controlled trial of stereotactic body radiotherapy (SBRT) versus conventionally hypofractionated radiotherapy (CRT) for the treatment of stage I medically inoperable non–small-cell lung cancer (OCOG-LUSTRE Trial). Eligible patients are randomized in a 2:1 fashion to either SBRT (48 Gy in 4 fractions for peripherally located lesions; 60 Gy in 8 fractions for centrally located lesions) or CRT (60 Gy in 15 fractions). The primary outcome of the study is 3-year local control, which we hypothesize will improve from 75% with CRT to 87.5% with SBRT. With 85% power to detect a difference of this magnitude (hazard ratio = 0.46), a 2-sided α = 0.05 and a 2:1 randomization, we require a sample size of 324 patients (216 SBRT, 108 CRT). Important secondary outcomes include overall survival, disease-free survival, toxicity, radiation-related treatment death, quality of life, and cost-effectiveness. A robust radiation therapy quality assurance program has been established to assure consistent and high quality SBRT and CRT delivery. Despite widespread interest and adoption of SBRT, there still remains a concern regarding long-term control and risks of toxicity (particularly in patients with centrally located lesions). The OCOG-LUSTRE study is the only randomized phase III trial testing SBRT in a medically inoperable population, and the results of this trial will attempt to prove that the benefits of SBRT outweigh the potential risks.
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