SAFETY Trial

  • Research type

    Research Study

  • Full title

    Surveillance After Extremity Tumour Surgery Trial

  • IRAS ID

    333892

  • Contact name

    Kenneth Rankin

  • Contact email

    kenneth.rankin1@nhs.net

  • Sponsor organisation

    The Newcastle upon Tyne Hospitals NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT03944798

  • Duration of Study in the UK

    7 years, 0 months, 1 days

  • Research summary

    Soft tissue sarcomas are rare cancers usually arising in the limbs. Patients require management at a specialist centre which in most cases involves surgery and radiotherapy. They then enter follow-up including CT chest scans and chest x-rays because the most likely site for the sarcoma to spread into is the lungs (metastases).
    Currently, follow up for soft tissue sarcoma patients varies depending on the treating sarcoma centre. Most patients receive at least a chest x-ray every 6 months to assess for lung metastases. At some centres patients undergo CT scans every 3 months which is more expensive and involves substantial doses of radiation. It is unclear whether there is any benefit from more intensive follow up imaging with CT scans versus the simpler follow up of 6 monthly chest x-rays.
    To answer this question the sarcoma team at McMaster University in Canada have set up a trial which is underway in several countries around the world. They are keen for some centres in the UK to join. Therefore, following a consensus at the British Sarcoma Group Meeting in March 2022, it was agreed that an application to Sarcoma UK would be submitted to allow the UK to recruit patients into the trial. This application was successful.
    There are three UK centres to be involved: the North of England Bone and Soft Tissue Tumour Service at Newcastle, the East Midlands Sarcoma Service and the Royal Orthopaedic Hospital at Birmingham. The aim will be to recruit 120 UK sarcoma patients into the trial and randomise the participants as per the protocol.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    24/NE/0107

  • Date of REC Opinion

    30 Jul 2024

  • REC opinion

    Further Information Favourable Opinion