Lomustine with or without reirradiation for first progression of glioblastoma: a pragmatic randomized phase III study

复发性胶质母细胞瘤总是一种致命的难治性癌症，预后很差。患者的生活质量较低，症状非常繁重。该项目提出了一项由研究者发起的第三阶段随机实用临床试验。我们将评估在洛莫司汀化疗的基础上加用放射治疗是否比单用洛莫司汀化疗对复发的胶质母细胞瘤患者有更好的疗效。这项研究将应用最低限度的患者资格标准，从而尽可能接近常规临床设置。将进行成本-效果分析，以调查在不同国家将放射治疗添加到洛莫司汀化疗中以支持循证决策的经济价值。如果成功，该项目的结果将定义一个新的循证标准的治疗复发性胶质母细胞瘤。这项拟议的研究可能会提高患者的存活率和生活质量，但也会改善卫生系统的可持续性。这是一个包括临床肿瘤学家、放射肿瘤学家、健康经济学家和患者代表在内的多学科和多方利益相关者联盟。研究设计成功地与患者进行了讨论。这项行动是癌症使命“诊断和治疗”项目集群的一部分。“

Recurrent glioblastoma is an invariably fatal refractory cancer with dismal prognosis. Patients suffer from low quality of life and very burdensome symptoms. This project is proposing an investigator-initiated phase III randomised pragmatic clinical trial. We will assess whether the addition of radiation treatment to lomustine chemotherapy has superior efficacy as compared to lomustine chemotherapy alone for treatment of patients with recurrent glioblastoma. The study will apply minimal patient eligibility criteria, and thus be as close as possible to the routine clinicalsetting. Cost-effectiveness analysis will be performed to investigate the economic value of adding radiation treatment to lomustine chemotherapy in different countries to support evidence-informed policy decisions. If successful, the outcomes of the project will define a new evidence-based standard of care for recurrent glioblastoma. The proposed research could lead to improved patient survival and quality of life but also improving health system sustainability. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, radiation oncologists, health economists and patient representatives. The study design was successfully discussed with patients. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment.”