CORE: A randomised trial of COnventional care versus Radioablation (stereotactic body radiotherapy (SBRT)) in Extracranial oligometastases (CRUK/14/038)

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Presentation transcript:

CORE: A randomised trial of COnventional care versus Radioablation (stereotactic body radiotherapy (SBRT)) in Extracranial oligometastases (CRUK/14/038) Chief Investigator: Dr Vincent Khoo Sponsor: The Royal Marsden NHS Foundation Trust Funder: Cancer Research UK 206 patients with NSCLC, breast or prostate cancer with ≤ 3 extracranial oligometastases SOC group May include chemotherapy, biological therapy, hormone therapy, palliative radiotherapy or observation at investigator’s discretion Follow up Patients are reviewed every 3 months with a clinical exam and tumour markers (where applicable) during years 1 and 2, and 6 monthly thereafter up to 5 years. Further staging and follow up imaging protocols are tumour type dependent. RANDOMISATION 1:1 SBRT + SOC group Dose and fractionation dependent on metastatic site SBRT to precede SOC CORE is a phase II/III multi-centre, non-blinded, randomised controlled trial comparing standard of care (SOC) with or without SBRT for extra-cranial metastases. Primary endpoint: Progression Free Survival (PFS) Target accrual : 206 patients The phase II component of CORE aims to demonstrate: Feasibility of randomised recruitment Deliverability of the study in an international multi-centre setting SBRT activity based on PFS across the three tumour types If all three aims are achieved additional funding will be sought to roll the study into parallel tumour-site specific phase III trials For more information contact: Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU), London, UK. CORE-icrctsu@icr.ac.uk