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

Contact information



Primary contact

Dr Paul Sanghera


Contact details

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Queen Elizabeth Medical Cancer Centre
B15 2TH
United Kingdom
+44 (0)121 472 1311

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Accelerated hypofractionation, Chemotherapy, Intensity Modulation and Evaluation of Dose Escalation in Oropharyngeal cancer: a non randomised study



Study hypothesis

To determine whether it is safe and feasible to deliver a 5 week schedule of dose escalated intensity modulated chemoradiotherapy for poor prognosis patients with Human Papillomavirus (HPV) negative and P16 negative locally advanced squamous carcinoma of the oropharynx (SCCOP) in the context of a feasibility study.

Ethics approval

West Midlands Research Ethics Committee, South Birmingham, ref. 12/WM/0112.

Study design

Single arm single centre non-randomised feasibility study

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Locally advanced squamous carcinoma of the oropharynx


Patients entered into the study will receive intensity modulated chemoradiotherapy (IMRT), 64Gy in 25F for 5 weeks. Chemotherapy (cisplatin) will also be given as standard practice once in the 1st week and once in the last week of radiotherapy.

Intervention type



Not Applicable

Drug names


Primary outcome measure

Full dose radiotherapy received as planned and the absence of consequential damage defined by the absence of Grade 3 mucositis at 3 months

Secondary outcome measures

1. Duration of Grade 3 mucositis: defined as the number of days of Grade 3 mucositis scored using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3
2. Incidence of acute Grade 4 toxicity defined according to the NCI CTCAE version 4
3. Incidence of ≥ Grade 3 late toxicity defined according to RTOG (see appendix 2) and CTCAE version 4 scoring systems
4. Complete response rate at 3 months defined as no clinically visible (including endoscopic evaluation), palpable or measurable disease on imaging OR the absence of residual tumour on directed biopsy/neck dissection. The primary tumour and regional lymph nodes will be considered separately
5. Two year local control defined as no re-appearance of tumour within primary site (including immediately adjoining anatomical sites) or regional lymph nodes after complete response
6. Two year disease free survival defined in whole days, as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years
7. Two year overall survival defined in whole days as the time from entry into the study until death from any cause. Patients will be censored at the date last seen alive. All patients will be followed up for at least 5-years
8. Incidence of feeding tube dependency at one year defined by the patient requiring supplementation of nutrition by a feeding tube

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Histologically proven, P16 negative SCCOP deemed suitable for radical primary chemoradiotherapy with curative intent requiring bilateral neck irradiation. Neoadjuvant chemotherapy and pre or post chemoradiation neck dissections are permitted
2. Only patients requiring bilateral radiotherapy
3. Age ≥18 and <75 years
4. World Health Organisation (WHO) performance status 0 or 1
5. Adequate bone marrow: absolute neutrophil count > 1,800 cells/mm3, platelets > 100,000 cells/mm3, haemoglobin > 8.0 g/dl
6. Creatinine clearance > 50 ml/minute
7. Informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Prior invasive malignancy (except basal cell carcinoma and cervical intraepithelial neoplasia) within last 3 years
2. Prior radiotherapy to the head and neck region
3. Pregnancy and/or lactation
4. Reproductive capability agreement to use contraceptive
5. Contraindications to cisplatin chemotherapy including active vascular disease (e.g. myocardial within last 6 months, angina and symptomatic peripheral vascular disease)
6. Non curative intent
7. Non squamous cell carcinoma histology
8. Nasophaynx, larynx, hypopharynx, salivary gland or sino-nasal primary site
9. Other physical or psychiatric disorder that may interfere with subject compliance, adequate informed consent, follow up or determine the causality of adverse events
10. Suitable for unilateral radiotherapy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
B15 2TH
United Kingdom

Sponsor information


University Hospitals Birmingham NHS Foundation Trust (UK)

Sponsor details

Mendelsohn Way
B15 2TH
United Kingdom
+44 (0)121 371 4185

Sponsor type




Funder type


Funder name

Queen Elizabeth Hospital Birmingham Charities (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

Basic results (scientific)

Publication list

2018 results in:

Publication citations

Additional files

Editorial Notes

26/02/2020: Link to basic results added to results (plain English) 07/02/2019: The sponsor details were updated. 06/02/2019: The following changes were made: 1. The recruitment start date was changed from 03/09/2012 to 02/11/2012. 2. The recruitment end date was changed from 02/12/2019 to 22/01/2014. 3. The ethics approval was added. 4. Publication reference added.