Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of the study is to identify markers that can be used to determine whether patients with oropharyngeal cancer will respond to certain treatments before they receive their treatments. This will mean that patients will receive the most appropriate treatment and this would likely result in the best outcome for them.

Who can participate?
Any patient who has had treatment for oropharyngeal cancer

What does the study involve?
The samples and information of the treatment for that patient will be obtained from their base hospital. The samples will then be tested for the biomarkers that are being studied. The results will then be analysed to see if the biomarkers can predict the response from the treatment that the patient had.

What are the possible benefits and risks of participating?
Since this is a retrospective study that looks at what treatments patients already have, then there is no risk to patients. The benefits are that the results may help future patients.

Where is the study run from?
The study is run from the Institute of Head and Neck Studies and Education at the University Hospitals Coventry.

When is study starting and how long is it expected to run for?
The study starts in May 2012 and is running for two years.

Who is funding the study?
Cancer Research UK

Who is the main contact?
Gemma Jones

Trial website

Contact information



Primary contact

Mrs Gemma Jones


Contact details

Clifford Bridge Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Improving treatment selection using PREDICtive and prognostic classifiers of Treatment Response for Head and Neck Cancers and dysplasia



Study hypothesis

Aims: The project will validate the use of molecular biomarkers to better select the management of individual patients with oropharyngeal cancer. This should improve survival and quality of care because patients will receive the treatments most likely to help them and avoid the unnecessary toxicity, morbidity and cost of potentially ineffective treatment.

Objectives: To develop and validate biomarker prognostic (PC) and treatment response classifiers (TRC) to select those patients with oropharyngeal cancers most likely to respond to chemoradiotherapy or surgery. A PC and TRC are mathematical functions that translates clinical factors and biomarker values into a set of prognostic and predictive outcomes, which select and stratify patients for treatment.

Background: Head and neck cancer (HNC) and its treatments have considerable quality of life effects and therapeutic, rehabilitative and social costs for patient and NHS. Survival is relatively poor and has not improved a lot despite a choice of new treatments. Therefore there is a need to improve health outcomes.One of the main reasons for the problems above is that tumours have different biological characteristics. There is a need for better methods of prognostication and treatment selection taking into account the biological characteristics of disease. Recently there have been several publications showing that certain immunohistological biomarkers strongly predict response to chemoradiotherapy and significantly enhanced survival in cohorts of patients that have been recruited during RCTs. These include HPV, p16, EGFR and Bcl-2, CA-9. These studies have involved single or at most two markers at a time, and have not incorporated other known established prognostic factors such as stage of disease or smoking status. Further more these findings have not been validated independently on other cohorts.

Ethics approval

NRES Committee Covenry & Warwickshire, 14 November 2011 ref: 10/H1210/9

Study design

Observational study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Head and neck cancer


The outcome data and samples of patients with oropharyngeal cancer receiving either chemoradiotherapy or surgery plus or minus chemo-radiotherapy are collated from each centre. Samples are then analysed using the selected biomarkers. Complex bioinformatics analysis is then undertaken to look at the prognostic and predictive effects of selected biomarkers.

Followed up for 36 months.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Survival measured at the end of the study

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Oropharyngeal (tonsil or base of tongue) squamous carcinoma
2. Has a minimum 3 year follow up or to recurrence or death if occured before 3 years
3. Treatment by chemoradiotherapy or by surgery +/- post operative RT or chemoradiotherapy
4. Has clinical data including TNM staging available
5. Formalin fixed, paraffin embedded tissue block available
6. Male & female participants

Participant type


Age group




Target number of participants

UK Sample Size: 1400

Participant exclusion criteria

1. No follow-up data
2. Not of stated primary site

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clifford Bridge Road
United Kingdom

Sponsor information


University Hospitals Coventry & Warwick (UK)

Sponsor details

University Suite
Clifford Bridge Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes