Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Radiation: Radical Radiotherapy (Conventional RT and SABR)Other: Non-investigational SACT
- Registration Number
- NCT02417662
- Lead Sponsor
- University College, London
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 340
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SACT + Radical Radiotherapy (Conventional RT and SABR) Radical Radiotherapy (Conventional RT and SABR) SACT 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. Systemic Anti-Cancer Therapy (SACT) alone Non-investigational 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.
- Primary Outcome Measures
Name Time Method Overall Survival From date of randomisation to the date of death, up to 36 months The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on overall survival
- Secondary Outcome Measures
Name Time Method Progression Free Survival Time from randomisation until progression or death, up to 36 months. The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on progression free survival
Toxicity (radiotherapy related toxicity Adverse events) From registration to up to 36 months after the first patient is randomised Safety analyses will be performed on all patients who received at least one dose of chemotherapy or fraction of SRT post-randomisation. Radiotherapy-related toxicity and early and late toxicity will be investigated. Adverse events will be compared between the two groups, as well as dose delays, reductions and compliance to chemotherapy and radiotherapy.
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 The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on local tumour control
Health Related Quality of Life using the EORTC-QLQ-C30 and EORTC-LC13 questionnaires From time of registration to time of death or up to 36 months The health related quality of life for each treatment arm will be assessed.
Trial Locations
- Locations (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
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