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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
11/08/2016
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr. Fiona McDonald
Recruitment target:
340
EudraCT number:
N/A
Contact details:
ctc.SARON@ucl.ac.uk
Lay summary:
SARON
Stereotactic Ablative Radiotherapy for Oligometastatic Non-small cell lung cancer. A randomised phase III trial
Description
Design:
SARON is a randomised, controlled phase III trial of systemic anti-cancer therapy (SACT) versus SACT+ radiotherapy in patients with oligometastatic (1-5 metastases) non-small cell lung cancer (NSCLC) patients. 

Sub Studies: 

Feasibility Assessment:
A feasibility assessment will be made after at least 50 patients have been randomised.

Thoracic SABR Safety:
This sub-study of the trial will assess toxicity of the first 20 patients receiving SABR to the thoracic metastases following conventional lung RT to the primary.

Treatment:
Within SARON patients will be randomised in a 1:1 ratio to either SACT or SACT plus radiotherapy. Those patients randomised to the Investigational Arm will receive either conventional RT or stereotactic ablative radiotherapy (SABR) to the lung primary and SABR and/or stereotactic radiosurgery (SRS) to the sites of metastases.
Key inclusion/exclusion criteria:
Patients must have histologically or cytologically confirmed NSCLC, without actionable mutations, staging with FDG PET-CT whole body scan and MRI brain or CT brain with IV contrast, synchronous primary disease and oligometastatic disease and between one and five metastatic lesions (up to max. of 3 organs), assessable according to RECIST v1.1 and suitable for SABR/SRS. Patients cannot have palliative radiotherapy to any tumour site prior to registration/randomisation.
Duration of recruitment:
Anticipated recruitment for the main trial will be 3 years. The Thoracic Safety Sub-Study of the trial will assess toxicity of the first 20 patients receiving SABR to the thoracic metastases following conventional lung RT to the primary, and the feasibility sub-study assessment will be made after at least 50 patients have been randomised.
Aim
Main Trial: The overall aim is to investigate the impact on overall survival of the addition of conventional RT and SABR/SRS to standard systemic therapy in the first line treatment of non-small cell lung cancer patients with one to three metastatic lesions.

Sub-Studies:

Feasibility Assessment: To assess practicality of achieving recruitment targets by comparing expected recruitment rate with actual recruitment rate, the logistics of delivering the investigational treatment and potential for contamination as patients may seek SABR/SRS outside of the trial.

Thoracic SABR Safety: To assess toxicity of patients receiving SABR to thoracic metastases following treatment of the primary lung tumour with conventional RT.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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