Comparing different treatment methods for cancer of the throat - A second look at the CompARE trial
Secondary analysis of trial data to compare different radiotherapy approaches and different chemotherapy regimens in terms of efficacy and swallowing outcomes, in patients with oropharyngeal cancer, using data from the phase III randomised CompARE trial. (CompARE 2ry analysis)
Funding
Why this trial
There is a global increase of the number of oropharyngeal cancers, mainly related to smoking history or HPV infection. This is mostly seen in men, and to a lesser extent in women.
Patients with intermediate- and high-risk cancer of the throat – called oropharyngeal cancer (OPC) – generally have worse outcomes than those with low-risk disease. Because of this, researchers have been exploring ways to intensify the treatment to improve their outcomes.
The CompARE trial is a large clinical study designed to test different treatment approaches for these higher-risk patients. It started in July 2015 and finished inclusion in January 2024, with a total of 794 participants enrolled.
The trial has collected a large amount of information, including patient-reported outcomes that measure the quality of life of the participants.
Why this intervention
During the trial, participating hospitals were given the option to use a newer radiotherapy planning method called the “5+5” contouring protocol, instead of the standard approach (called “10+0”).
Although this newer method has already been widely adopted, there is still limited clinical trial evidence to confirm whether it indeed leads to better outcomes.
For this reason, researchers now plan to analyse data obtained during the CompARE trial to directly compare patient outcomes between the two radiotherapy approaches (“5+5” vs. standard method).
They are taking advantage of a natural experiment that happened halfway through the trial, i.e. a change in radiotherapy practices due to guidelines recommendations while the evidence for that change is not strong.
In addition, the project will also compare the different approaches to chemotherapy delivery that were given to patients to assess if there’s any difference in terms of efficacy and quality of life.
Overall, the aim of the project is to find out which of the standard treatments used during the CompARE trial lead to the best outcomes.
Trial design
Some preliminary analysis was conducted on CompARE trial data, presented at ESTRO2025 (The annual congress of the European SocieTy for Radiotherapy and Oncology)
This project will perform a complete detailed analysis of this work, including data review and additional follow up.
The aim is to analyse
- treatment received
- quality of life + ease of swallowing
- side effects
- survival outcomes
Partners
Piers Gaunt
Principal Biostatistician and Team Leader,
Cancer Research UK Clinical Trials Unit (CRCTU),
University of Birmingham
Professor Hisham Mehanna,
Chair of Head and Neck Surgery,
Director, Institute for Head and Neck Studies and Education (InHANSE)
University of Birmingham
Our role
Why we support this trial
Funding
zeze
References
Mehanna, H., et al., Oropharyngeal carcinoma related to human papillomavirus. BMJ, 2010. 340: p.c1439
National Cancer Intelligence Network, Profile of Head and Neck Cancers in England: Incidence, Mortality and Survival. 2010
Ang, K.K., et al., Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med, 2010. 363(1): p. 24-35
Mehanna, H., Gaunt, P., Kong, A. et al. CompARE: study protocol for a phase III randomised controlled platform trial comparing alternative regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer. Trials 25, 50 (2024).
Grégoire V, Evans M, Le QT et al. Delineation of the primary tumour Clinical Target Volumes in laryngeal, hypopharyngeal, oropharyngeal and oral cavity squamous cell carcinoma: AIRO, CACA, DAHANCA, EORTC, GEORCC, GORTEC, HKNPCSG, HNCIG, IAG-KHT, LPRHHT, NCIC CTG, NCRI, NRG Oncology, PHNS, SBRT, SOMERA, SRO, SSHNO, TROG consensus guidelines. Radiother Oncol. 2018 Jan;126(1):3-24.