Suppli Morten H, Af Rosenschold Per Munck, Pappot Helle, Dahl Benny, Morgen Søren S, Vogelius Ivan R, Engelholm Svend A
Department of Oncology, Section of Radiotherapy, Rigshospitalet, Copenhagen, Denmark.
Spine Unit, Department of Orthopedic Surgery, Rigshopitalet, Copenhagen, Denmark.
J Radiosurg SBRT. 2016;4(1):S1-S9.
Current treatment standard for patients with metastatic spinal cord compression (MSCC) is decompressive surgery followed by radiotherapy. Stereotactic radiosurgery (SRS) could be considered a treatment option for MSCC for patients with minor neurologic deficits. If SRS is safely and effectively delivered with equivalent functional outcome, the patients would avoid the risks associated with an invasive procedure. This paper presents the design of a non-inferiority clinical trial evaluating the safety, tolerability and feasibility of SRS vs. current standard treatment for patients with MSCC. Patients fulfilling inclusion criteria will be randomized 1:1 to each arm. The primary endpoint is ability to walk six weeks after treatment. Secondary endpoints are levels of pain, bladder control, quality of life, response rate, toxicity and number of treatment days. 65 patients in each arm are required for the power of 89% to detect a clinically relevant inferior outcome.
转移性脊髓压迫症（MSCC）患者目前的治疗标准是减压手术，随后进行放射治疗。对于有轻微神经功能缺损的MSCC患者，立体定向放射外科手术（SRS）可被视为一种治疗选择。如果SRS能够安全有效地实施并取得同等的功能结果，患者将避免与侵入性手术相关的风险。本文介绍了一项非劣效性临床试验的设计，该试验旨在评估SRS与MSCC患者当前标准治疗相比的安全性、耐受性和可行性。符合纳入标准的患者将按1:1随机分配至每组。主要终点是治疗六周后行走的能力。次要终点包括疼痛程度、膀胱控制、生活质量、缓解率、毒性和治疗天数。每组需要65名患者，以89%的检验效能检测具有临床意义的较差结果。
