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Brief Title: Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer
Official Title: Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer. A Randomised Phase III Trial
Study ID: NCT02417662
Brief Summary: The trial will assess the addition of stereotactic ablative radiotherapy (SABR) to standard anti-cancer therapy (SACT) in patients with oligometastatic non-small cell lung cancer. Patients will be randomised to receive either standard treatment alone (SACT) or standard treatment with conventional radiotherapy (RT) and SABR.
Detailed Description: SARON is a confirmatory phase III study examining the efficacy and safety of stereotactic ablative radiotherapy (SABR) and conventional radiotherapy (RT) alongside standard chemotherapy in patients with oligometastatic non-small cell lung cancer. Current treatment for this group of patients is systemic anti-cancer therapy. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines. There is sufficient evidence regarding the safety of SABR, its effect on local control and a possible impact on overall survival. This trial will further examine overall survival, progression free survival and local control, as well as toxicity, feasibility, patient reported outcomes and health resource use. There will be a feasibility analysis performed after 50 patients have been randomised. This will assess the practicality of achieving recruitment targets, logistics of delivering the experimental treatment and the potential for contamination (as patients may seek SABR outside of the trial if randomised to the non SABR arm). There will also be a parallel thoracic SABR safety and feasibility study after recruitment and treatment of 20 patients with thoracic metastases. This is a multicentre randomised phase III study based on patients with oligometastatic NSCLC. Trial arms: Control Arm: systemic anti-cancer therapy alone (SACT) Experimental Arm: SACT plus radical RT to primary and SABR and/or SRS to metastases
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLH, London, England, United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Bristol Royal Infirmary, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
BEATSON, Glasgow, , United Kingdom
Royal Surrey County Hospital, Guildford, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Charing Cross Hospital, London, , United Kingdom
Guy's and St Thomas's Hospital, London, , United Kingdom
Mount Vernon Cancer Centre, London, , United Kingdom
St Bart's Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
The James Cook University Hospital, Middlesbrough, , United Kingdom
Freeman Hospital, Newcastle, , United Kingdom
City Hospital, Nottingham, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Clatterbridge Cancer Centre, Wirral, , United Kingdom
Name: Fiona McDonald
Affiliation: Royal Marsden NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR