Department of Radiation Oncology, Iridium Cancer Network, Wilrijk, Antwerp, Belgium.
University of Antwerp, Molecular Imaging, Pathology, Radiotherapy & Oncology (MIPRO), Edegem, Antwerp, Belgium.
Radiat Oncol. 2018 Aug 20;13(1):152. doi: 10.1186/s13014-018-1096-9.
In an oligometastatic setting, metastasis-directed treatment could render patients disease free, possibly for a protracted interval. Stereotactic ablative radiotherapy (SABR) is one of the treatment modalities that can be offered to these patients. In addition, the radiobiological qualities of SABR are promising for the use in perceived radioresistant tumours. There is also emerging evidence that SABR can stimulate the immune response, and a specific therapeutic window may exist for the optimal use of radiotherapy as an immune adjuvant. However, when SABR is considered for non-spine bone or lymph node metastases, the optimal fractionation schedule is not yet known.
The DESTROY-trial is a non-randomized prospective phase I trial determining a regimen of choice for patients with non-spine bone and lymph node metastases. A total of 90 patients will be included in three different treatment regimens. They will be offered stereotactic ablative radiotherapy in 5, 3 or 1 fractions. Dose-limiting toxicity will be recorded as primary endpoint. Acute and late toxicity, local response and local recurrence, and progression-free survival are secondary endpoints. Liquid biopsies will be collected throughout the course of this study from the second fractionation schedule on.
Despite its almost universal use in (oligo-)metastatic patients, the level of evidence supporting radical local treatment in general, and stereotactic radiotherapy in particular, is low. This prospective phase I trial will evaluate different SABR regimens for metastases and the differences in immune-stimulatory effects.
The Ethics committee of the GZA Hospitals (B099201732915) approved this study on 05/07/2017. Amendment for translational research was approved on 06/02/2018. Trial registered on Clinicaltrials.gov ( NCT03486431 ) on 03/04/2018 - Retrospectively registered.
在寡转移的情况下，针对转移灶的治疗可以使患者无疾病状态，并且可能会持续很长一段时间。立体定向消融放疗（SABR）是可用于此类患者的治疗方法之一。此外，SABR 的放射生物学特性对于治疗被认为具有放射抵抗性的肿瘤具有很大的潜力。有证据表明 SABR 可以刺激免疫反应，并且可能存在一个特定的治疗窗口，使放疗成为免疫佐剂的最佳选择。然而，当考虑对非脊柱骨或淋巴结转移灶进行 SABR 治疗时，最佳分割方案尚不清楚。
DESTROY 试验是一项非随机前瞻性 I 期试验，旨在确定非脊柱骨和淋巴结转移患者的首选治疗方案。该试验共纳入 90 例患者，分为 3 组接受不同的治疗方案。所有患者均接受 SABR 治疗，分割剂量分别为 5、3 或 1 次。主要终点为剂量限制毒性。急性和晚期毒性、局部反应和局部复发、无进展生存期为次要终点。在本研究的第二个分割方案开始时，将通过液体活检收集整个研究过程中的生物样本。
尽管 SABR 已广泛应用于（寡）转移性患者，但支持根治性局部治疗，尤其是立体定向放疗的证据水平较低。这项前瞻性 I 期试验将评估不同的 SABR 方案治疗转移灶的效果，并比较其免疫刺激作用的差异。
该研究于 2017 年 7 月 5 日经 GZA 医院伦理委员会（B099201732915）批准。2018 年 2 月 6 日，该研究被批准用于转化研究。该研究于 2018 年 3 月 4 日在 Clinicaltrials.gov 注册（NCT03486431）-回顾性注册。
