Neuroblastoma is the commonest solid tumour of childhood with an incidence of approximately 100 patients per year in the UK. The majority of cases are high risk disease, and the survival of these patients is approximately 40% or below at five years. Radiotherapy to the primary tumour site is standard practice following chemotherapy and surgery. It improves local control and may improve survival. However, the radiation tolerance of adjacent critical normal structures such as the kidneys and liver limit the dose of radiotherapy which can be delivered. This depends on the size and precise location of the neuroblastoma. Up to 50% of patients currently receive less than adequate radiotherapy doses. Recently developed sophisticated radiotherapy techniques such as - Intensity Modulated Arc Radiotherapy (IMAT) - offer 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 of damage. Gains et al have demonstrated, in a theoretical study, the ability of IMAT to deliver the standard radiotherapy dose to the tumour, avoiding normal structures, with greater reliability than conventional radiotherapy.
The aim of this feasibility study is to asses if, and to what extent, dose escalation is safely possible using IMAT in children with neuroblastoma; defining what increased dose might be suitable for use in future Phase III randomised studies. Acute and late toxicities will be monitored.
Please note that the trials team cannot give individuals clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible
| Chief Investigator: |
Dr Mark Gaze |
| Coordinating Sponsor: |
University of Birmingham |
| Funders: |
CRUK (Cancer Research UK) |
| Disease Site: |
Abdomen |
| Trial Type: |
Closed, randomised, UK multicentre |
| Status: |
Closed/ In follow-up |
ISRCTN Study ID:
|
10746820 |
| Open to new sites? |
No |
| Recruitment start date: |
February 2017 |
| Recruitment end date |
February 2020 |
| CRCTU Trial Management Team: |
Children's Cancer Trials Team |
| Trial E-mail Address: |
imat@trials.bham.ac.uk |