一项评估同时进行场内推量螺旋断层放疗治疗 1-3 个脑转移瘤的 II 期多中心研究。
A phase II multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases.
机构信息
Division of Radiation Oncology, Department of Oncology, University of Western Ontario and London Regional Cancer Program, London Health Sciences Centre, London, ON N6A4L6, Canada.
出版信息
Radiat Oncol. 2012 Mar 21;7:42. doi: 10.1186/1748-717X-7-42.
BACKGROUND
Our research group has previously published a dosimetric planning study that demonstrated that a 60 Gy/10 fractions intralesional boost with whole-brain radiotherapy (WBRT) to 30 Gy/10 fractions was biologically equivalent with a stereotactic radiosurgery (SRS) boost of 18 Gy/1 fraction with 30 Gy/10 fractions WBRT. Helical tomotherapy (HT) was found to be dosimetrically equivalent to SRS in terms of target coverage and superior to SRS in terms of normal tissue tolerance. A phase I trial has been now completed at our institution with a total of 60 enrolled patients and 48 evaluable patients. The phase II dose has been determined to be the final phase I cohort dose of 60 Gy/10 fractions.
METHODS/DESIGN: The objective of this clinical trial is to subject the final phase I cohort dose to a phase II assessment of the endpoints of overall survival, intracranial control (ICC) and intralesional control (ILC). We hypothesize HT would be considered unsuitable for further study if the median OS for patients treated with the HT SIB technique is degraded by 2 months, or the intracranial progression-free rates (ICC and ILC) are inferior by 10% or greater compared to the expected results with treatment by whole brain plus SRS as defined by the RTOG randomized trial. A sample size of 93 patients was calculated based on these parameters as well as the statistical assumptions of alpha = 0.025 and beta = 0.1 due to multiple statistical testing. Secondary assessments of toxicity, health-related quality-of-life, cognitive changes, and tumor response are also integrated into this research protocol.
DISCUSSION
To summarize, the purpose of this phase II trial is to assess this non-invasive alternative to SRS in terms of central nervous system (CNS) control when compared to SRS historical controls. A follow-up phase III trial may be required depending on the results of this trial in order to definitively assess non-inferiority/superiority of this approach. Ultimately, the purpose of this line of research is to provide patients with metastatic disease to the brain a shorter course, dose intense, non-invasive radiation treatment with equivalent or improved CNS control/survival and health-related quality-of-life/toxicity profile when compared to SRS radiotherapy.
TRIAL REGISTRATION
Clinicaltrials.gov - NCT01543542.
背景
我们的研究小组之前发表了一项剂量学规划研究，表明 60Gy/10 次瘤内推量联合全脑放疗（WBRT）至 30Gy/10 次与立体定向放射外科（SRS）加量 18Gy/1 次、全脑放疗 30Gy/10 次在生物学上等效。螺旋断层放疗（HT）在靶区覆盖方面与 SRS 具有等效性，在正常组织耐受方面优于 SRS。我们机构现已完成了一项 I 期试验，共纳入 60 名患者，其中 48 名可评估患者。II 期剂量已确定为 60Gy/10 次的最终 I 期队列剂量。
方法/设计：本临床试验的目的是对最终 I 期队列剂量进行 II 期评估，以评估总生存、颅内控制（ICC）和瘤内控制（ILC）的终点。我们假设，如果接受 HT SIB 技术治疗的患者的中位 OS 降低 2 个月，或颅内无进展率（ICC 和 ILC）比 RTOG 随机试验中全脑加 SRS 治疗的预期结果低 10%或更多，则 HT 将不适合进一步研究。根据这些参数以及由于多次统计检验而导致的α=0.025 和β=0.1 的统计假设，计算出 93 名患者的样本量。还将对毒性、健康相关生活质量、认知变化和肿瘤反应进行二次评估，并将其纳入该研究方案。
讨论
总之，该 II 期试验的目的是评估与 SRS 历史对照相比，这种非侵入性的 SRS 替代方法在中枢神经系统（CNS）控制方面的效果。可能需要进行后续的 III 期试验，以根据该试验的结果确定这种方法的非劣效性/优越性。最终，该研究旨在为脑转移患者提供一种更短疗程、剂量密集、非侵入性的放疗，与 SRS 放疗相比，具有等效或改善的 CNS 控制/生存和健康相关生活质量/毒性特征。
试验注册
Clinicaltrials.gov-NCT01543542。
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