CORE

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: In follow-up

Trial details

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 aimed to recruit 230 patients over a period of three years. Participants were randomised to receive either standard care alone (115 patients) or standard care with SBRT (115 patients). Participants will be followed up for a further five years. 
 
 The phase II study aims to demonstrate:

1. feasibility of recruitment
2. deliverability of the study in a multi-centre setting and
3. 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.

Further information for potential participants

Patient Information Sheet (Breast)

Patient Information Sheet (Lung)

Patient Information Sheet (Prostate)

Further information for healthcare professionals

Protocol

Further information

Chief Investigator: Dr Vincent Khoo, The Royal Marsden NHS Foundation Trust

ICR-CTSU Scientific Lead: Dr Emma Hall

Trial management contact: [email protected]

ISRCTN: 45961438

Sponsor: The Royal Marsden NHS Trust Foundation

Funding: Cancer Research UK (CRUK/14/038)

View CORE on the National Institute for Health Research website: NIHR - Be Part Of Research

A plain English summary from Cancer Research UK will be added once available.

Information flyers

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.