SARON

• Research type

  Research Study

• Full title

  Stereotactic ablative radiotherapy for oligometastatic non-small cell lung cancer. A randomised phase III trial.

• IRAS ID

  180166

• Contact name

  Fiona McDonald

• Contact email

  Fiona.McDonald@rmh.nhs.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  NCT02417662

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  The SARON trial is a phase III trial looking to see if adding radiotherapy (conventional, stereotactic radiotherapy and / or stereotactic radiosurgery (give to the brain)) to standard chemotherapy can improve overall survival in non-small cell lung cancer (NSCLC) patients with 1-3 metastases.

  The target accrual is 340 patients. The trial is funded by Cancer Research UK and sponsored by University College London. The trial will be coordinated by the CR UK & UCL Cancer Trials Centre.

  • All patients in the trial will receive 2 cycles of chemotherapy.
  • After two cycles, patients will be assessed for progression. Those that have not progressed will be randomised.
  • Patients randomised to the control group (chemotherapy only) will receive 2 more cycles of chemotherapy.
  • Patients randomised to the investigational group (chemotherapy plus radiotherapy group) will receive 2 more cycles of chemotherapy followed by radiotherapy.
  • All patients will be followed up for 3 years after completing trial treatment or until death.

  A safety sub-study will look at the first 20 patient receiving stereotactic radiotherapy to their chest to assess the level of lung inflammation within the first 3 months after the end of treatment.

  A feasibility sub-study will make an assessment after the first 50 patients have been randomised. This will review the practicality of achieving recruitment targets, assess the logistics of delivering the radiotherapy treatment, and the potential for patients seeking stereotactic radiotherapy off study if randomised to the control group.

  Primary Endpoint: Main trial - Overall survival
  Sub-Studies:
  Feasibility Sub- Study
  • Recruitment rate
  • Logistical practicalities
  • Assess if patients seek stereotactic radiotherapy outside of the trial.

  Safety Sub- Study
  Grade 3-5 lung inflammation

  Secondary Endpoint: Main trial:
  • Progression-free survival
  • Local control of lung tumour and all metastases
  • New distant metastases
  • Overall survival
  • Quality of life

  Safety Sub- Study
  • Other side effects

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  15/WM/0392

• Date of REC Opinion

  2 Dec 2015

• REC opinion

  Further Information Favourable Opinion