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是一种总是致命的难治性癌症，预后不良。患者的生活质量低，症状非常繁重。该项目提出了一项由制药商发起的III期随机实用临床试验。我们将评估在洛莫司汀化疗基础上加用放疗治疗复发性胶质母细胞瘤患者的疗效是否上级洛莫司汀单独化疗。本研究将采用最低患者合格性标准，因此尽可能接近常规临床环境。将进行成本-效果分析，以调查不同国家在洛莫司汀化疗基础上增加放射治疗的经济价值，以支持循证决策。如果成功，该项目的结果将为复发性胶质母细胞瘤定义一个新的循证护理标准。拟议的研究可能会改善患者的生存率和生活质量，同时也会提高卫生系统的可持续性。这是一个多学科和多方利益相关者的联盟，包括临床肿瘤学家，放射肿瘤学家，卫生经济学家和患者代表。与患者成功讨论了研究设计。这一行动是癌症使命“诊断和治疗”项目组的一部分。

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.”