Department of Oncology, Juravinski Cancer Centre, McMaster University, 699 Concession Street, Hamilton, ON, L8V 5C2, Canada.
Radiat Oncol. 2021 Sep 3;16(1):170. doi: 10.1186/s13014-021-01897-0.
Stereotactic Body Radiotherapy (SBRT) has shown effectiveness in treating bone metastases to alleviate pain. The benefit of SBRT may be further harnessed especially when radiating disease from primary malignancies with low alpha-beta ratios in order to maximize the magnitude and durability of pain relief. However, such an approach has not been studied in a prospective trial. We look to assess single-fraction SBRT for painful non-spinal bone metastases from radioresistant primaries.
Forty patients will be enrolled on an open label, phase II single arm trial to receive a single fraction of SBRT (15-20 Gray) to all sites of bone metastases requiring treatment for pain relief. Eligible patients will include those with primary malignancies consisting of prostate cancer, breast cancer, renal cell carcinoma, or melanoma. The primary endpoint is pain response at 3 months post-treatment using the Brief Pain Inventory. Secondary endpoints include pain response at 1 month and 6 months post-treatment, toxicity, patient-reported quality of life, re-irradiation or salvage surgery, and local control.
This study will evaluate the efficacy of single-fraction SBRT on painful bone metastases from primary cancers with low alpha-beta ratios. These data will be valuable to promote future randomized trials and support clinical implementation. Trial registration Clinicaltrials.gov, NCT04177056. Date of registration: November 26, 2019. https://clinicaltrials.gov/ct2/show/NCT04177056.
立体定向体部放射治疗（SBRT）已被证明在治疗骨转移以缓解疼痛方面具有疗效。当从α-β比值较低的原发性恶性肿瘤放射治疗疾病时，SBRT 的益处可以进一步得到利用，以最大限度地提高疼痛缓解的幅度和持久性。然而，这种方法尚未在前瞻性试验中进行研究。我们旨在评估单次 SBRT 治疗对来自放射抗拒性原发性肿瘤的疼痛性非脊柱骨转移。
将有 40 名患者参加一项开放标签、Ⅱ期单臂试验，对所有需要缓解疼痛的骨转移部位进行单次 SBRT（15-20 戈瑞）治疗。符合条件的患者将包括前列腺癌、乳腺癌、肾细胞癌或黑色素瘤等原发性恶性肿瘤患者。主要终点是治疗后 3 个月使用简短疼痛清单评估疼痛反应。次要终点包括治疗后 1 个月和 6 个月的疼痛反应、毒性、患者报告的生活质量、再放疗或挽救性手术以及局部控制情况。
本研究将评估单次 SBRT 治疗低α-β比值原发性癌症所致疼痛性骨转移的疗效。这些数据将有助于促进未来的随机试验，并为临床实施提供支持。试验注册Clinicaltrials.gov，NCT04177056。注册日期：2019 年 11 月 26 日。https://clinicaltrials.gov/ct2/show/NCT04177056。
