SURGERY FOR SPINAL CORD COMPRESSION DUE TO CANCER

癌症引起的脊髓压迫手术

• 批准号: 2096478
• 负责人: Roy Andrew Patchell
• 金额: $ 21.78万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-08-24 至 1997-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2096478
• 关键词: cancer complication; clinical trials; human subject; human therapy evaluation; neoplasm /cancer; neoplasm /cancer radiation therapy; neoplasm /cancer surgery; spinal cord injury; spinal cord surgery

Spinal cord compression caused by metastatic cancer is the second most common neurologic complication of cancer and affects 5-15% of all cancer patients with solid tumors. With radiation therapy, the current standard treatment, less than half of patients are ambulatory after treatment. Uncontrolled studies have suggested that the combination of direct decompression of the spinal cord by surgical removal of the tumor actually causing the cord compression plus postoperative radiotherapy may be substantially better than radiation alone. However, only uncontrolled nonrandomized studies have been reported, and the apparent advantage of surgery found in these preliminary reports could be entirely due to preselection of good prognosis patients. We propose to do a multi-institutional prospective randomized trial to determine the actual value (if any) of direct decompressive surgery. Cancer patients with clinical and radiographic (or MRI) evidence of cord compression will be randomly assigned to treatment with either radiation alone (3,000 cGy) or direct decompressive surgery followed by radiotherapy (3,000 cGy). There will be a total of 200 patients (100 in each arm). The surgery will be performed using the most direct approach to the tumor, and the tumor causing the spinal cord compression will be removed. Intraoperative stabilization of the spine (using metallic rods or reconstruction of the vertebral body with acrylic) will be done if spinal instability is present. Major endpoints of the study will be ambulatory rate post treatment, pain relief, preservation of bowel and bladder function, recurrence rate, and time to recurrence. The main potential benefit of this study will be to determine the value of aggressive spinal surgery in the treatment of metastatic epidural cord compression. Given the poor results with radiation alone, any improvement in ambulatory rate or pain relief that results from surgery would be a major advance in the treatment of this fairly common oncologic problem. On the other hand, if aggressive spinal surgery is shown to be of no value, then the practice should be discontinued. Only a carefully controlled randomized trial will decide the issue.

转移性癌症引起的脊髓压迫是第二大 癌症的常见神经系统并发症，影响所有癌症的5-15% 实体瘤患者。 放射治疗，目前的标准 治疗后，不到一半的患者可以走动。 非对照研究表明， 通过手术切除肿瘤来进行脊髓减压 实际上导致脊髓压迫加上术后放疗可能 比单纯的辐射要好得多。 然而，只有不受控制的 非随机研究已经报道， 在这些初步报告中发现的手术可能完全是由于 预选预后良好的患者。 我们建议做一个 多机构前瞻性随机试验，以确定实际的 直接减压手术的价值（如有）。 癌患者 脊髓压迫的临床和影像学（或MRI）证据将 随机分配至单独放射治疗（3，000 cGy）或 直接减压手术后进行放射治疗（3，000 cGy）。 那里 总共将有200名患者（每组100名）。 做手术会 使用最直接的方法对肿瘤进行手术， 导致脊髓受压的部分将被移除 术中 脊柱稳定（使用金属棒或重建脊柱） 如果脊柱不稳， 礼物 本研究的主要终点为术后门诊率。 治疗，缓解疼痛，保护肠道和膀胱功能， 复发率和复发时间。 的主要潜在好处 这项研究将确定积极的脊柱手术在 转移性硬膜外脊髓压迫症的治疗 鉴于穷人 单独放疗的结果，步行率或疼痛的任何改善 手术带来的缓解将是 治疗这种相当常见的肿瘤问题。 另一方面如果 积极的脊柱手术被证明是没有价值的，那么这种做法 应该停止。 只有一个精心控制的随机试验 将决定这个问题。