Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer. a Randomised Phase III Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- University College, London
- Enrollment
- 340
- Locations
- 19
- Primary Endpoint
- Overall Survival
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 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 Outcomes
- 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)
- 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)