GALA-5 Long Term Follow up Study

• Research type

  Research Study

• Full title

  Long term follow up of patients from the GALA-5 trial: an Evaluation of the Tolerability and Feasibility of combining 5-Amino-Levulinic Acid (5-ALA) with Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma

• IRAS ID

  180783

• Contact name

  Mark Phillips

• Contact email

  ctc.GALA5@ucl.ac.uk

• Sponsor organisation

  University College London

• Eudract number

  2010-022496-66

• ISRCTN Number

  ISRCTN77105850

• Clinicaltrials.gov Identifier

  NCT01310868

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  Summary of Research
  This study is linked with the GALA-5 trial. During the trial, 5 patients of the 72 entered into the trial were declared lost to follow up by the sites that entered them into the trial. There are also 12 patients on the trial who may or may not still be alive. However, because end of trial for GALA-5 was declared on 07/03/2014, follow up data can no longer be collected on these patients. Of the 72 patients entered into the trial, we have received death forms for 47 patients, 7 were not diagnosed with glioblastoma post-operatively and therefore not eligible for follow up, and 1 withdrew consent.
  Therefore, this follow up study aims to obtain data (date of death, cause of death and date last known to be alive) from the NHS Information Centre (NHS IC) for these eligible patients in GALA-5 who may or may not still be alive. This will be a single request to the NHS IC for data. This data will then be incorporated into the existing GALA-5 dataset. This will allow the study to sufficiently complete the existing dataset, which allow a comprehensive analysis of overall survival to be completed. All data collection will be done through the NHS Information Centre, so patients will not need to be contacted.

  Summary of results
  72 patients entered the trial, of the 59 patients that were eligible to take part. The study showed that it is possible to give wafers with 5-ALA guided surgery and it was tolerated. Further studies are required to look at the potential benefit in more detail.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  15/EE/0390

• Date of REC Opinion

  23 Oct 2015

• REC opinion

  Further Information Favourable Opinion