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Randomised part II trial of olaparib, chemotherapy or olaparib and cediranib in sufferers with platinum-resistant ovarian most cancers (OCTOVA): a research protocol.
BMJ Open. 2021 Jan 15;11(1):e041463
Authors: Mansouri A, McGregor N, Dunn R, Dobbie S, Holmes J, Collins L, Nicum S
Summary
INTRODUCTION: Sufferers relapsing inside 12 months of platinum-based chemotherapy normally have a poorer response to subsequent therapies. Up to now, in depth analysis into the mechanism of resistance to platinum brokers within the remedy of ovarian most cancers has not resulted in improved responses or longer survival. Additional experimental work and medical trials with novel brokers are due to this fact justified to deal with this unmet want.Sufferers with ovarian, fallopian tube or main peritoneal most cancers that has relapsed inside 12 months of platinum-based chemotherapy will probably be randomised with stratification for BReast CAncer gene (BRCA) standing, prior poly (ADP-ribose) polymerase (PARP) publicity and prior antiangiogenic remedy into weekly paclitaxel (chemotherapy), olaparib or the mix of cediranib and olaparib. They are going to be adopted till illness development or unacceptable toxicity develops. Our trial design permits two investigations. We’ll evaluate the efficacy and tolerability of single-agent olaparib with weekly paclitaxel. We will even evaluate the efficacy and tolerability of olaparib with the mix of olaparib and cediranib. The required pattern measurement of 138 members (46 per arm) was calculated utilizing a 20% one-sided kind I error, 80% energy and 15% dropout fee. Recruitment will final 34 months with a follow-up of 18 months.
METHODS AND ANALYSIS: ETHICS AND DISSEMINATION: This research will probably be performed beneath a UK Medicines and Healthcare Merchandise Regulatory Company Scientific Trials Authorisation. Approval to conduct the research was obtained from the accountable authority earlier than starting the research. The sponsor will retain possession of all knowledge arising from the trial. We purpose to publish this analysis in a specialist peer-reviewed scientific journal on research completion. EudraCT quantity: 2016-000559-28, ethics reference quantity: 16/LO/2150.
TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN14784018, clinicaltrials.gov: NCT03117933; Pre-results.
PMID: 33452192 [PubMed – as supplied by publisher]
