奥拉帕利、化疗或奥拉帕利和西地尼布治疗铂耐药卵巢癌患者的随机 II 期试验（OCTOVA）：研究方案。
Randomised phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol.
机构信息
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Oncology Clinical Trials Office (OCTO), Department of Oncology, University of Oxford, Oxford, UK.
出版信息
BMJ Open. 2021 Jan 15;11(1):e041463. doi: 10.1136/bmjopen-2020-041463.
INTRODUCTION
Patients relapsing within 12 months of platinum-based chemotherapy usually have a poorer response to subsequent treatments. To date, extensive research into the mechanism of resistance to platinum agents in the treatment of ovarian cancer has not resulted in improved responses or longer survival. Further experimental work and clinical trials with novel agents are therefore justified to address this unmet need.Patients with ovarian, fallopian tube or primary peritoneal cancer that has relapsed within 12 months of platinum-based chemotherapy will be randomised with stratification for BReast CAncer gene (BRCA) status, prior poly (ADP-ribose) polymerase (PARP) exposure and prior antiangiogenic therapy into weekly paclitaxel (chemotherapy), olaparib or the combination of cediranib and olaparib. They will be followed until disease progression or unacceptable toxicity develops. Our trial design permits two investigations. We will compare the efficacy and tolerability of single-agent olaparib with weekly paclitaxel. We will also compare the efficacy and tolerability of olaparib with the combination of olaparib and cediranib. The required sample size of 138 participants (46 per arm) was calculated using a 20% one-sided type I error, 80% power and 15% dropout rate. Recruitment will last 34 months with a follow-up of 18 months.
METHODS AND ANALYSIS
ETHICS AND DISSEMINATION: This study will be conducted under a UK Medicines and Healthcare Products Regulatory Agency Clinical Trials Authorisation. Approval to conduct the study was obtained from the responsible authority before beginning the study. The sponsor will retain ownership of all data arising from the trial. We aim to publish this research in a specialist peer-reviewed scientific journal on study completion. EudraCT number: 2016-000559-28, ethics reference number: 16/LO/2150.
TRIAL REGISTRATION NUMBER
ISRCTN: ISRCTN14784018, clinicaltrials.gov: NCT03117933; Pre-results.
简介
接受铂类化疗后 12 个月内复发的患者对后续治疗的反应通常较差。迄今为止，针对卵巢癌铂类耐药机制的广泛研究并未改善反应或延长生存时间。因此，有必要进一步开展实验工作和临床试验，以评估新型药物。
铂类化疗后 12 个月内复发的卵巢癌、输卵管癌或原发性腹膜癌患者，将根据 BReast CAncer 基因（BRCA）状态、既往多聚（ADP-核糖）聚合酶（PARP）暴露和既往抗血管生成治疗进行分层，随机分为每周紫杉醇（化疗）、奥拉帕利或西地尼布联合奥拉帕利组。患者将持续接受治疗，直至疾病进展或出现无法耐受的毒性。我们的试验设计允许进行两项研究。我们将比较单药奥拉帕利与每周紫杉醇的疗效和耐受性。我们还将比较奥拉帕利与奥拉帕利联合西地尼布的疗效和耐受性。根据 20%单侧Ⅰ型错误、80%功效和 15%失访率计算，需要 138 名参与者（每组 46 名）的样本量。招募工作将持续 34 个月，随访时间为 18 个月。
方法和分析
伦理和传播：本研究将在英国药品和保健产品监管局临床试验授权下进行。在开始研究之前，已从主管部门获得开展研究的批准。申办者将保留试验产生的所有数据的所有权。我们计划在研究完成后，在专业的同行评议科学期刊上发表这项研究。EudraCT 编号：2016-000559-28，伦理参考编号：16/LO/2150。
试验注册编号
ISRCTN：ISRCTN14784018，clinicaltrials.gov：NCT03117933；预结果。
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