Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer
SARON
1 other identifier
interventional
140
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable nonsmall-cell-lung-cancer
Started Aug 2016
Longer than P75 for not_applicable nonsmall-cell-lung-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedStudy Start
First participant enrolled
August 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
May 6, 2026
April 1, 2026
10 years
March 20, 2015
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on overall survival
From date of randomisation to the date of death, up to 36 months
Secondary Outcomes (6)
Progression Free Survival
Time from randomisation until progression or death, up to 36 months.
Toxicity (radiotherapy related toxicity Adverse events)
From registration to up to 36 months after the first patient is randomised
Local Tumour Control by assessment of tumours at baseline and at progression according to RECIST v1.1
From time of randomisation to time of progression or death, up to 36 months
New distant metastasis-free survival
Time from randomisation until presence of new distant metastasis or death, up to 36 months
Overall Survival (from start of induction SACT)
From date of start of induction SACT to date of death, up to 36 months
- +1 more secondary outcomes
Study Arms (2)
Systemic Anti-Cancer Therapy (SACT) alone
ACTIVE COMPARATORThe 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.
SACT + Radical Radiotherapy (Conventional RT and SABR)
EXPERIMENTALSACT followed by radical RT (conventional or SABR) to the primary and SABR to the metastatic sites. 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.
Interventions
There is no intervention in the control group, patients will receive SACT. 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.
Radical radiotherapy (conventional or SABR) to primary and SABR to the metastases
Eligibility Criteria
You may qualify if:
- Patient ≥ 18 years
- Histologically or cytologically confirmed NSCLC.
- Staging with FDG PET-CT whole body scan and MRI brain within 45 days prior to registration (but prior to commencement of first cycle of SACT). \[Note: Brain CT with IV contrast can be performed instead (within 45 days prior to registration). However, if brain metastases are evident on the brain CT then a brain MRI must be performed prior to randomisation, i.e. the Brain CT is sufficient for registration into the trial but not for randomisation if it is positive for brain metastases, in which case a brain MRI must be performed\]
- ECOG performance status 0 to 1 (prior to commencement of first cycle of SACT).
- Patient presenting with primary disease +/- lymph nodes and synchronous oligometastatic disease (1-5 lesions in up to a maximum of 3 organs).
- Patient is deemed fit to receive 12 weeks of induction systemic anti-cancer therapy, according to local guidelines and assessment.
- Patient is deemed fit to receive radical RT (either conventional RT or SABR) to primary disease +/- lymph node and SABR/SRS to 1-5 metastases according to local guidelines and assessment.
- Primary tumour +/- lymph node suitable for radical RT (either conventional RT or SABR).
- metastatic lesions in up to a maximum of 3 organs, assessable according to RECIST v1.1 and all of which are suitable for SABR/SRS (only one site of metastasis or primary tumour needs to be measurable according to RECIST v1.1).
- i. If brain metastasis present, the NHS commissioning guidelines need to be met for intracranial SRS (≤20 cc) (or equivalent for Wales, Scotland \& Northern Ireland in line with standard of care).
- ii. Lymph nodes included in the N1-3 categories of the IASLC 2009 staging criteria are treated in the conventional radiotherapy volume and are not counted as metastases.
- iii. Lymph nodes not included in the N1-3 categories of the IASLC 2009 staging criteria, e.g. pelvic lymph nodes, are counted as metastases.
- iv. For bone metastases pre-SABR stabilisation should be considered as clinically appropriate. This does not exclude the patient from the study.
- Acceptable lung function for radical lung radiotherapy as assessed according to local policy. Note: Potential thoracic sub-study patients will need to complete pulmonary function tests pre-randomisation
- No relevant co-morbidities, including UIP pulmonary fibrosis and connective tissue disorders.
You may not qualify if:
- Patient has had palliative radiotherapy to any tumour site prior to registration or requires palliative radiotherapy prior to randomisation.
- Presence of an actionable molecular aberration.
- Patients currently receiving VEGF inhibitors.
- One or more metastases previously treated with alternative ablative treatment.Note: Surgical ablation (partial or total excision biopsy) is permitted for palliative or diagnostic purposes (e.g. for molecular analysis). Treatment for any residual disease/tumour bed will be at the discretion of treating clinician/MDT. Resected/ablated metastases will count towards the total number of metastases.
- Patient has received any previous treatment for this NSCLC malignancy.
- Metastasis in sites where normal radiotherapy OAR constraints cannot be met.
- Brain metastasis within the brainstem.
- Patients who have more than five sites of metastases in up to 3 organs prior to trial registration.
- Primary tumour or metastases causing direct invasion or high clinical suspicion of direct invasion of the wall of a major blood vessel, oesophagus, trachea, proximal bronchial tree, stomach, intestines or mesenteric lymph nodes or cutaneous metastases or diffuse serosal metastases.
- Malignant pleural or pericardial effusion.
- Bilateral adrenal metastases.
- History of prior malignant tumour likely to interfere with the protocol treatment, (patients without evidence of disease for at least 1 year or a non-melanoma skin tumour or early cervical cancer are eligible).
- Women who are pregnant or breast feeding.
- Stage III disease with extensive nodal disease not treatable in radical radiotherapy field.
- Leptomeningeal disease
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Cancer Research UKcollaborator
Study Sites (19)
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
Guy's and St Thomas's Hospital
London, United Kingdom
St Bart's Hospital
London, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
Christie Hospital
Manchester, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, 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
Related Publications (1)
Conibear J, Chia B, Ngai Y, Bates AT, Counsell N, Patel R, Eaton D, Faivre-Finn C, Fenwick J, Forster M, Hanna GG, Harden S, Mayles P, Moinuddin S, Landau D. Study protocol for the SARON trial: a multicentre, randomised controlled phase III trial comparing the addition of stereotactic ablative radiotherapy and radical radiotherapy with standard chemotherapy alone for oligometastatic non-small cell lung cancer. BMJ Open. 2018 Apr 17;8(4):e020690. doi: 10.1136/bmjopen-2017-020690.
PMID: 29666135DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fiona McDonald
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2015
First Posted
April 16, 2015
Study Start
August 19, 2016
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
May 6, 2026
Record last verified: 2026-04