PARADIGM: Olaparib And Radiotherapy In newly-diagnosed Glioblastoma
Research type
Research Study
Full title
Short-course radiotherapy plus olaparib for newly diagnosed glioblastoma in patients unsuitable for radical chemoradiation: a randomised phase II clinical trial preceded by a lead-in phase I dose escalation study.
IRAS ID
149204
Contact name
Anthony Chalmers
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde Health Board
Eudract number
2014-001216-19
ISRCTN Number
ISRCTN52658296
Research summary
Glioblastoma is the commonest primary brain tumour and is currently incurable. Radiotherapy is effective in shrinking tumours and can increase life expectancy, but only by a few months. lt is not possible to increase the dose of radiotherapy because of the risk of damage to the normal brain tissue. Patients aged 70 years and over, and younger patients who are in poor health, get less benefit and more side effects from high dose radiotherapy and chemotherapy. We would like to test a new drug called olaparib in the treatment of these patients with glioblastoma. Laboratory studies have shown that olaparib increases the effectiveness of radiotherapy against tumour cells but is unlikely to increase the risk of damage to the normal brain. In this trial we will first ask whether olaparib can be safely combined with radiotherapy in this patient group, and also find out what dose of olaparib to use. We will then ask whether patients treated with olaparib plus radiotherapy live longer and have better quality of life than patients treated with radiotherapy alone.
REC name
West of Scotland REC 1
REC reference
14/WS/1096
Date of REC Opinion
13 Nov 2014
REC opinion
Further Information Favourable Opinion