HIPPO version 1.0

  • Research type

    Research Study

  • Full title

    A randomized phase II trial of Hippocampal Sparing versus Conventional Whole Brain Radiotherapy after surgical resection or radiosurgery in favourable prognosis patients with 1-10 brain metastases

  • IRAS ID

    150747

  • Contact name

    Nick McNally

  • Contact email

    ctc.sponsor@ucl.ac.uk

  • Sponsor organisation

    University College London

  • Clinicaltrials.gov Identifier

    NCT02147028

  • Duration of Study in the UK

    5 years, 0 months, 1 days

  • Research summary

    Participants will be patients diagnosed with 1 – 4 brain metastases (brain tumours which have grown from cancer cells which have spread to the brain from a cancer elsewhere in the body) and who have had surgery or focused radiotherapy (“stereotactic radiosurgery” or SRS) to the brain to try to control the metastases and are now to receive whole brain radiotherapy. Whole brain radiotherapy is radiotherapy to the whole of the brain including the sites of already treated tumours. This is given as extra treatment to the already operated or SRS treated metastases and to try to prevent other tumours growing elsewhere in the brain, from cancer cells which may have spread there but are still too small to be detected on a scan.
    However, whole brain radiotherapy can reduce cognitive function, which is the brain’s ability to process information. This means functions such as memory, learning, problem solving and decision making can be affected. It is thought this is because whole brain radiotherapy may slightly damage the left and right hippocampi which are areas of the brain important for such functions.
    In this study we aim to test whether avoiding irradiating the hippocampi during whole brain radiotherapy (hippocampal sparing whole brain radiotherapy) will help to preserve cognitive function.
    HIPPO will be carried out across approximately 13 hospitals in the UK. Participants will be randomly allocated (that is, by chance) to receive either standard whole brain radiotherapy or ‘hippocampal sparing’ whole brain radiotherapy. There is an equal chance of receiving one or other of these treatments. Whole brain radiotherapy or ‘hippocampal sparing’ whole brain radiotherapy will be administered as 10 separate doses or ‘fractions’. Patients will then be seen at 2, 4, 6, 9, 12, 18 and 24 months after completion of the radiotherapy to assess health status and cognitive function.

  • REC name

    North West - Greater Manchester East Research Ethics Committee

  • REC reference

    14/NW/1500

  • Date of REC Opinion

    2 Feb 2015

  • REC opinion

    Further Information Favourable Opinion