PROTONS VERSUS PHOTONS FOR HEPATOCELLULAR CARCINOMA
Research type
Research Study
Full title
A PHASE III RANDOMIZED TRIAL OF PROTONS VERSUS PHOTONS FOR HEPATOCELLULAR CARCINOMA
IRAS ID
299998
Contact name
Ganesh Radhakrishna
Contact email
Sponsor organisation
NRG Oncology
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 1 days
Research summary
Radiotherapy is a treatment option for patients with Hepatocellular Carcinoma (cancer of the liver) which is confined to and has not spread outside of the liver.
This trial includes patients with cancer of the liver and it will focus on the differences in survival, disease progression, treatment side effects and quality of life using proton beam therapy or PBT (a newer form of radiotherapy) compared with standard photon or x-ray radiotherapy. PBT uses accelerated protons to deliver radiation and can be directed more precisely to the tumour than standard radiotherapy. This reduces the amount of normal tissue surrounding the tumour receiving radiation that isn’t wanted. We know from international use of PBT that it is a safe treatment and is thought to cause less damage to normal tissues.
PBT does remain a controversial treatment due to the cost and an unproven benefit in overall survival. However, single arm studies suggest superior results compared with photon radiotherapy studies. This randomised trial will enrol 186 patients (half of the participants will receive PBT & half will receive standard radiotherapy) from a number of international centres and seeks to directly answer if protons are superior to photons. The choice of PBT (protons) or standard radiotherapy (photons) will be decided randomly by computer to minimise bias. In the UK we are aiming to recruit approximately 8 patients who will be treated at The Christie NHS Foundation Trust in Manchester (1 of only 2 PBT centres in the UK). After treatment patients will be followed up regularly for up to 10 years and will have regular blood tests, scans and be asked to complete questionnaires looking at fatigue and quality of life.
Results of this trial will be presented at international conferences and published in peer reviewed medical journals.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0107
Date of REC Opinion
25 Jun 2024
REC opinion
Further Information Favourable Opinion