A randomised trial of COnventional care versus Radioablation (stereotactic body radiotherapy) for Extracranial oligometastases
Disease site: Breast cancer, lung cancer, prostate cancer.
Treatment modality: Radiotherapy
Status: Open to recruitment
CORE is a phase II/III, multicentre, non-blinded, parallel group randomised controlled trial in patients with breast, prostate or non-small cell lung cancer (NSCLC) primary cancer to evaluate if the addition of stereotactic body radiotherapy (SBRT) to standard therapy improves progression-free survival outcomes in patients with extra-cranial oligometastases.
Phase II of CORE will recruit 206 patients over a period of three years. Participants will be randomised to receive either standard care alone (103 patients) or standard care with SBRT (103 patients). Participants will be followed up for a further five years.
The phase II study aims to demonstrate:
- feasibility of recruitment
- deliverability of the study in a multi-centre setting and
- activity of SBRT, based on progression-free survival, across the three tumour types (breast, prostate and NSCLC).
If all three aims are achieved, CORE will roll into parallel, tumour-site specific phase III trials.
Chief Investigator: Dr Vincent Khoo, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
Sponsor: The Royal Marsden NHS Trust Foundation
Funding: Cancer Research UK (CRUK/14/038)
Links to CORE on the UK Clinical Trials Gateway and a plain English summary from Cancer Research UK will be added once available.
CORE breast flyer v1.0
CORE lung flyer v1.0
Publications and presentations
Gaya A, Hawkins M, Kirby A, Ahmed M, Van As N, Syndikus I, Franks K, Jain S, Hall E, Khoo V; on behalf of the CORE Trial Management Group. CORE - Randomised trial of Conventional care versus Radioablation (stereotactic body radiotherapy (SBRT)) for Extracranial metastases. Presented at: Radiosurgery Society’s SRS/SBRT Scientific Meeting; 2016 June; FL, USA.