CompARE Trial, Version 1.0
Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
HN3001, CRCTU Reference Number
Duration of Study in the UK
8 years, 5 months, 1 days
Oropharyngeal cancer (OPC) is a disease in which malignant cells form in the tissue of the oropharynx. OPC is usually treated by chemoradiotherapy, which is considered the standard treatment in the UK. Tobacco smoking, alcohol consumption and Human Papillomavirus (HPV) are the main causes of OPC. There are two types of OPC:
Low-risk OPC: These are patients whose cancers are caused by HPV and who do not smoke or smoke very little. These low-risk OPC respond very well to chemoradiotherapy with a cure rate of more than 90%.
Higher-risk OPC: These are patients whose cancers are caused mainly by heavy tobacco smoking or alcohol intake. About half of these higher-risk cancers also have HPV in them. These higher-risk OPC respond less well to the chemoradiotherapy, with cure rates of about 50-70%.
As a result, new treatment paradigms for low-risk OPC are being considered aiming to improve the toxicity profile of treatment by using less intensive chemotherapy or radiotherapy regimens. Conversely, the poor outcomes of patients with higher-risk OPC suggest that they may benefit from intensification of treatment to improve outcomes. The higher-risk groups of patients represent >70% of cases in the UK.
The CompARE trial is needed to determine the optimum treatment of higher-risk OPC aiming to improve survival outcomes without significantly worsening toxicity and Quality of Life compared to the current treatment of chemoradiotherapy. Approximately 650 patients with higher-risk OPC will be randomised from hospitals around the UK to one of the treatment regimens involving intensifying current standard of care by the intensification of the chemotherapy or radiotherapy components or the addition of surgery.
Also incorporated into the trial is an Quality of Life component and an optional Qualitative Recruitment Investigation aiming to optimise recruitment and consenting and an optional translational component involving collection of tissue, blood and oral fluid samples.
West Midlands - Edgbaston Research Ethics Committee
Date of REC Opinion
27 Nov 2014
Further Information Favourable Opinion