Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): Study protocol for a randomized phase II trial
Stereotactic ablative radiotherapy for comprehensive treatment of oligometastatic tumors (SABR-COMET): Study protocol for a randomized phase II trial
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DOI：
10.1186/1471-2407-12-305
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发表时间：
2012-07-23
期刊：
影响因子：
3.8
通讯作者：
Senan, Suresh
中科院分区：
文献类型：
--
作者：
Palma, David A.;Haasbeek, Cornelis J. A.;Senan, Suresh
背景：立体定向消融放疗（SABR）已成为寡转移性疾病患者的一种新的治疗选择。SABR提供精确、高剂量、低分割放射治疗，并实现极好的局部控制率。使用SABR治疗的少转移性疾病患者的生存结果似乎很有希望，但结论受到患者选择的限制，并且在大多数研究中缺乏足够的对照。这项多中心随机II期试验的目标是评估综合低转移性SABR治疗方案对5个转移性癌病变患者的总体生存和生活质量的影响，与单独接受标准护理治疗的患者相比。方法：根据转移数量进行分层（1-3 vs. 4-5）后，患者将被随机分配到第1组：当前标准护理治疗，第2组：标准护理治疗+ SABR到所有已知疾病部位。患者将分别以1:2的比例随机分配到第1组：第2组。对于接受SABR的患者，放疗剂量和分割取决于转移部位和是否接近关键的正常结构。这项研究的目标是在4年内累计99名患者。主要终点是总生存期，次要终点包括生活质量、毒性、无进展生存期、病变控制率和进一步化疗/全身治疗的周期数。讨论：本研究将评估SABR对临床结果和生活质量的影响，以确定是否可以为选定的少转移性疾病患者实现长期生存，并将为可能的III期研究设计提供信息。
Background: Stereotactic ablative radiotherapy (SABR) has emerged as a new treatment option for patients with oligometastatic disease. SABR delivers precise, high-dose, hypofractionated radiotherapy, and achieves excellent rates of local control. Survival outcomes for patients with oligometastatic disease treated with SABR appear promising, but conclusions are limited by patient selection, and the lack of adequate controls in most studies. The goal of this multicenter randomized phase II trial is to assess the impact of a comprehensive oligometastatic SABR treatment program on overall survival and quality of life in patients with up to 5 metastatic cancer lesions, compared to patients who receive standard of care treatment alone.Methods: After stratification by the number of metastases (1-3 vs. 4-5), patients will be randomized between Arm 1: current standard of care treatment, and Arm 2: standard of care treatment + SABR to all sites of known disease. Patients will be randomized in a 1:2 ratio to Arm 1:Arm 2, respectively. For patients receiving SABR, radiotherapy dose and fractionation depends on the site of metastasis and the proximity to critical normal structures. This study aims to accrue a total of 99 patients within four years. The primary endpoint is overall survival, and secondary endpoints include quality of life, toxicity, progression-free survival, lesion control rate, and number of cycles of further chemotherapy/systemic therapy.Discussion: This study will provide an assessment of the impact of SABR on clinical outcomes and quality of life, to determine if long-term survival can be achieved for selected patients with oligometastatic disease, and will inform the design of a possible phase III study.