IMAT-Neuroblastoma

• Research type

  Research Study

• Full title

  A randomised phase I/II study of Intensity Modulated Arc Therapy techniques in abdominal neuroblastoma

• IRAS ID

  188540

• Contact name

  Sean Jennings

• Contact email

  researchgovernance@contacts.bham.ac.uk

• Sponsor organisation

  University of Birmingham

• Duration of Study in the UK

  7 years, 0 months, 2 days

• Research summary

  Neuroblastoma is the commonest solid tumour of childhood. The majority of cases are high risk disease, and the survival of these patients is only around 30% at five years. Radiotherapy to the primary tumour site is standard practice. It improves local control and may improve survival. However the radiation tolerance of adjacent critical normal structures can limit the dose of radiotherapy that can be delivered. A recently developed way of delivering radiotherapy - Intensity Modulated Arc Radiotherapy (IMAT) offers a potential way to overcome some of the limitations through much better shaping of the volume treated to a high dose, and better avoidance of organs at risk (OAR) of damage
  
  This study aims to see if, and to what extent, dose escalation is safely possible in children with abdominal neuroblastoma using both IMAT and conventional radiotherapy techniques.

  This is an unblinded, multicentre randomised UK trial. 50 patients, aged 18 months or older at diagnosis with high risk abdominal neuroblastoma who require radical radiotherapy will be randomised to receive either the 'intended' standard dose (21Gy) or an 'intended' experimental dose (36Gy). Pre-treatment dosimetry will use established normal tissue constraints to ensure that over-treatment of OAR does not occur and that they are not damaged. This may mean that in some patients the full 36Gy dose is not given, and a lower *actual* dose is therefore the compromise outcome. Radiotherapy plans will be prepared for each patient using both conventional and IMAT techniques and the plan judged to have the best balance between target volume coverage to the randomised dose allocation, and sparing of OAR will be chosen for delivery.

  Having defined an increased dose which can safely be delivered to the majority (80%) of patients, a randomised phase III trial powered to detect superiority of the increased dose over the standard will be planned.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  16/LO/2186

• Date of REC Opinion

  21 Dec 2016

• REC opinion

  Favourable Opinion