Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial
Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-016-1178-7
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发表时间：
2016-02-02
期刊：
影响因子：
2.5
通讯作者：
Bussink, Johan
中科院分区：
文献类型：
--
作者：
Braam, Petra;Lambin, Philippe;Bussink, Johan
背景：疼痛的脊柱转移瘤采用常规放射治疗已有数十年，但三分之一的患者治疗后疼痛缓解不足，五分之一的患者需要再次治疗。立体定向放射治疗是一种在不增加治疗副作用的情况下增加脊柱转移瘤的剂量，具有潜在的更持久的缓解作用，从而有望显著提高生活质量的方法。方法/设计：本研究是一项多中心前瞻性随机临床试验，比较了传统放射治疗(1×8GY)和立体定向放射治疗(1×20GY)对脊柱转移癌疼痛缓解和生活质量的影响。共有386名患者将在两个治疗组之间随机分配。除了通过荷兰简明疼痛清单来衡量疼痛之外，还将衡量生活质量和成本效益。主要结果是治疗后6周疼痛减轻。次要结果将是疼痛起效时间、疼痛缓解时间、与健康相关的生活质量和毒性，以及成本效益。讨论：本研究探讨在不增加治疗相关副作用的情况下，与传统放射治疗相比，立体定向放射治疗有症状的脊柱转移瘤是否可以提高疼痛缓解程度。这些结果将有助于患者治疗的最优化和个体化。
Background: Painful spinal metastases have been treated with conventional radiotherapy for decades, but one-third of the patients have insufficient pain relief after treatment and one-fifth need retreatment. Stereotactic radiotherapy is a method to increase the dose in the spinal metastases with a potentially longer lasting palliative effect without increasing the side effects of the treatment and thereby is expected to improve the quality of life significantly.Methods/Design: This study is a multicenter prospective randomized clinical trial comparing conventional radiotherapy (1 x 8Gy) with stereotactic radiotherapy (1 x 20Gy) for pain reduction and quality of life in patients with painful spinal metastases. A total of 386 patients will be randomized between the two treatment groups. Besides pain measured by the Dutch Brief Pain Inventory, quality of life and cost-effectiveness also will be measured. The primary outcome is pain reduction at 6 weeks after treatment. Secondary outcomes will be the time to pain response, duration of pain relief, health-related quality of life and toxicity, as well as cost-effectiveness.Discussion: This study investigates whether stereotactic radiotherapy with dose escalation for symptomatic spinal metastases can lead to improved pain reduction as compared to conventional radiotherapy without an increase of treatment-related side effects. These results will contribute to the optimization and individualization of the treatment for the patient.