Siva Shankar, Kron Tomas, Bressel Mathias, Haas Marion, Mai Tao, Vinod Shalini, Sasso Giuseppe, Wong Wenchang, Le Hien, Eade Thomas, Hardcastle Nicholas, Chesson Brent, Pham Daniel, Høyer Morten, Montgomery Rebecca, Ball David
Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia.
University of Melbourne, Royal Parade, Parkville, 8006, Australia.
BMC Cancer. 2016 Mar 4;16:183. doi: 10.1186/s12885-016-2227-z.
Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases.
METHODS/DESIGN: The TROG 13.01/ALTG 13.001 clinical trial is a multicentre unblinded randomised phase II study. Eligible patients have up to three metastases to the lung from any non-haematological malignancy, each < 5 cm in size, non-central targets, and have all primary and extrathoracic disease controlled with local therapies. Patients are randomised 1:1 to a single fraction of 28Gy versus 48Gy in four fractions of SABR. The primary objective is to assess the safety of each treatment arm, with secondary objectives including assessment of quality of life, local efficacy, resource use and costs, overall and disease free survival and time to distant failure. Outcomes will be stratified by number of metastases and origin of the primary disease (colorectal versus non-colorectal primary). Planned substudies include an assessment of the impact of online e-Learning platforms for lung SABR and assessment of the effect of SABR fractionation on the immune responses. A total of 84 patients are required to complete the study.
Fractionation schedules have not yet been investigated in a randomised fashion in the setting of oligometastatic disease. Assuming the likelihood of similar clinical efficacy in both arms, the present study design allows for exploration of the hypothesis that cost implications of managing potentially increased toxicities from single fraction SABR will be outweighed by costs associated with delivering multiple-fraction SABR.
ACTRN12613001157763 , registered 17th October 2013.
立体定向消融体部放疗（SABR）正逐渐成为一种用于精确照射肺部肿瘤的非侵入性方法。然而，理想的剂量/分割方案尚不清楚。本研究的主要目的是评估在肺寡转移背景下单次和多次分割SABR的安全性和疗效。
方法/设计：TROG 13.01/ALTG 13.001临床试验是一项多中心非盲随机II期研究。符合条件的患者有来自任何非血液系统恶性肿瘤的最多三个肺转移灶，每个转移灶大小<5 cm，非中央靶区，且所有原发性和胸外疾病均通过局部治疗得到控制。患者按1:1随机分配至单次28Gy分割与48Gy分四次分割的SABR治疗组。主要目的是评估每个治疗组的安全性，次要目的包括评估生活质量、局部疗效、资源使用和成本、总生存期和无病生存期以及远处转移发生时间。结果将按转移灶数量和原发性疾病起源（结直肠癌与非结直肠癌原发性）进行分层。计划中的子研究包括评估在线电子学习平台对肺部SABR的影响以及SABR分割对免疫反应的影响。共需要84名患者完成本研究。
在寡转移疾病背景下，尚未以随机方式研究分割方案。假设两组临床疗效相似，本研究设计允许探索以下假设：单次分割SABR潜在增加的毒性管理成本将被多次分割SABR的相关成本所抵消。
ACTRN12613001157763，于2013年10月17日注册。
