Overview of the Research
The Head and Neck Research team is led by Mr Michael Ho, Consultant Oral and Maxillofacial Surgeon. The team has a portfolio of clinical trials investigating novel treatment methods for head and neck cancers. The broad aims of our research work are;
- Improve quality of life for head and neck cancer patients.
- Reduce the toxicity of treatment.
- Lower cancer recurrence risks.
“To develop enhanced and novel treatments in order to improve survival and quality of life for our patients.”
For further information please contact the team on:
T: 01274 366369
The Research Team
Trials open and actively recruiting patients
Head & Neck 5000
Head and Neck 5000 is a study evaluating head and neck cancer across the UK. Head & Neck 5000 closed to recruitment at the end of December 2014. A total of 5511 people from across 76 UK centres are taking part in the study. Study participants provide information about their lives, including their backgrounds, lifestyle and quality of life, as well as their experience of cancer. It will provide detailed information on the factors that influence cancer survival in the UK, and the psychological impact that living with head and neck cancer can have on people. Questionnaires were sent out to participants 4 months and 12 months after enrolment in the study and further data was collected from the medical notes. Further follow-up at 3 – 5 years post consent is currently underway. The follow-up involves a questionnaire to participants and data collection from the medical notes.
NIMRAD: (A randomised placebo-controlled trial of synchronous NIMorazole versus RADiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab)
This trial is looking at using radiotherapy and the drug nimorazole to treat people with head and neck cancer.
Most cancers have some cells with a low level of oxygen. These are more difficult to kill with radiotherapy than cancer cells with a normal oxygen level. Nimorazole is a drug that gets into the cells with a low level of oxygen. These cells are then more likely to be killed by radiotherapy.
In this trial, doctors will compare nimorazole with a dummy drug (placebo) to find out:
- Whether giving nimorazole with radiotherapy is a better treatment than radiotherapy alone
- The side effects of nimorazole
CompARE:- (Phase III randomised controlled trial Comparing Alternative Regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer)
This trial is for people who have intermediate or high risk oropharyngeal cancer. Oropharyngeal cancer is cancer of the middle part of the throat (the oropharynx). The oropharynx includes:
- the back third of your tongue
- the soft area at the back of the roof of the mouth (the soft palate)
- the tonsils and two ridges of tissue in front of and behind the tonsils
- the back wall of your throat
Doctors usually treat oropharyngeal cancer with a combination of the chemotherapy drug cisplatin and radiotherapy. This is called chemoradiotherapy. In this trial doctors want to compare this treatment with 4 other treatments to see which is best for people with intermediate and high risk oropharyngeal cancer. They also want to find out how the treatment might affect their day to day lives.
LISTER:- (A feasibility, multicentre randomised controlled trial assessing the effectiveness of Lugol’s Iodine to assist surgical excision of epithelial dysplasia in the oral cavity and oropharynx)
This trial is for people having surgery to remove abnormal cells from the lining of their mouth or part of the throat behind the mouth (oropharynx). This abnormal cell growth is called dysplasia. Dysplasia can range from being slightly abnormal to very abnormal. Cancer is more likely to develop in very abnormal cells.
We know that removing these abnormal cells can reduce the risk of cancer developing. But it is often difficult for surgeons to clearly see where the abnormal cells end and normal cells begin. Lugol’s iodine has been used in other parts of the body to show where abnormal cells are. Researchers think it might help surgeons during surgery to remove dysplasia from the mouth and part of the throat behind the mouth. Areas of dysplasia can be called lesions.
To find this out researchers need to do a clinical trial with a large number of people. But before a large clinical trial can be done they need to find out if people are willing to take part. This is called a feasibility study.
PQIP (Perioperative Quality Improvement Programme)
PQIP is a new initiative from the NIAA-HSRC, working on behalf of the Royal College of Anaesthetists and a broad range of stakeholders, aimed at improving patient outcomes from major surgery.
PQIP measures complications, mortality and patient reported outcome from major non-cardiac surgery. The ambition is to deliver real benefits to patients by supporting clinicians in using data for improvement. The pilot programme is being supported by the Health Foundation, who are funding research which will develop our understanding of the barriers and enablers to quality improvement at local level.
Trials in set-up
PATHOS (Post-operative Adjuvant Treatment for HPV-positive Tumours)
Oropharyngeal cancer caused by Human Papillomavirus (HPV) infection is increasing in incidence in the UK and other developed countries. It affects younger patients and has a better prognosis than most other head and neck cancers. Patients cured of their disease often have to live for several decades with the side-effects of their treatment which can be permanent and have a major impact on quality of life. The PATHOS study will recruit approximately 242 patients from around the UK over three years. The aim is to tailor treatment for patients with HPV-positive oropharyngeal cancer to reduce side-effects, particularly swallowing problems, which have the major impact on quality of life.
Oropharyngeal cancer is a type of cancer that can affect the throat, tonsils and back of the tongue. Many oropharyngeal cancers are caused by a virus called Human Papillomavirus (HPV), a common virus that we will almost all be affected by during our lives, usually without any illness at all. We don’t understand why HPV causes cancers to develop but the good news is that cancers caused by HPV usually respond well to treatment. This study aims to identify the best way of treating oropharyngeal cancers that are caused by HPV. At the moment, cancers caused by HPV are treated like any other cancer in the Head and Neck and the survival rate is very good. This study is looking to see if the treatment can be modified to reduce the risk of side-effects caused by the treatment.
Trials in follow-up phase
De-ESCALaTE HPV (Determination of Epidermal growth factor receptor-inhibitor (cetuximab) versus Standard Chemotherapy (cisplatin) early And Late Toxicity Events in Human Papillomavirus-positive oropharyngeal squamous cell carcinoma)
This trial is looking at the side effects of treatment for people who have cancer of the oropharynx. About half of oropharynx cancers are caused by a specific virus called Human Papillomavirus (HPV). Oropharynx cancer is usually treated by cisplatin chemo-radiotherapy, which is considered the standard treatment in the UK. HPV-related oropharynx cancer appears to respond very well to many treatments such as cisplatin chemo-radiotherapy, surgery and other types of chemo-radiotherapy. Recently, cetuximab chemo-radiotherapy has been found in studies to be as good as cisplatin chemo-radiotherapy (standard treatment) in treating oropharynx cancer. In addition, cetuximab chemo-radiotherapy has been shown to result in fewer side effects. DE-ESCALaTE will assess if treatment with cetuximab results in less short-term and long-term side effects in patients with HPV-related oropharynx cancer compared to those treated with cisplatin.
DeESCALaTE is now closed to recruitment. Patient follow-up continues.
LIHNCS (Lugol’s Iodine in Head and Neck Cancer Surgery)
LIHNCS is a Bradford sponsored multicentre randomised control trial. This trial is looking at using a dye made from iodine during surgery to remove cancers of the mouth or throat. This dye is called Lugol’s iodine. During surgery, the surgeon can see where the cancer stops and where normal tissue begins. But there may be abnormal (pre cancerous) cells around the area that the doctor cannot see. If these are left behind, they could develop into cancer. The aim of this trial is to find out if using Lugol’s iodine stain can help surgeons to identify precancerous tissue so that it can be removed with the tumour.
LIHNCS is now closed to recruitment. Patient follow-up continues.
HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis)
HOPON is a study looking to assess methods of prevention for osteoradionecrosis (ORN). Bone exposed to radiation can sometimes break down because of a decreased blood supply resulting in ORN. Hyperbaric oxygen (HBO) is currently offered as the standard treatment for ORN and works by increasing the oxygen supply to the jaw, this study is aiming to evaluate if HBO can also prevent ORN from developing. HOPON will evaluate if HBO works to prevent ORN in people having dental surgery or jaw surgery after radiotherapy for the treatment of head and neck cancer.
HOPON is now closed to recruitment.
DAHANCA-21 (Hyperbaric oxygen for the treatment of mandibular osteoradionecrosis)
DAHANCA-21 is a study looking to evaluate treatment for osteoradionecrosis. Bone exposed to radiation can sometimes break down because of a decreased blood supply which may result in osteoradionecrosis (ORN). Hyperbaric oxygen (HBO) is currently offered as the standard treatment for ORN and works by increasing the oxygen supply to the jaw. This study will assess the effectiveness of HBO as a treatment for ORN.
DAHANCA-21 is now closed to recruitment.
TITAN (Trial of Induction TPF Therapy in Advanced Head & Neck Cancer)
TITAN is a randomised controlled trial conducted in patients with previously untreated locally advanced head and neck squamous cell carcinoma. The study is looking at chemotherapy before surgery, this induction chemotherapy combines 3 drugs; docetaxel, cisplatin and fluorouracil (TPF). TITAN is looking to address the potential survival advantage of TPF induction chemotherapy prior to surgery and radiotherapy. The aim of the trial is to see if having induction chemotherapy before standard treatment helps people with locally advanced squamous cell cancer of the head and neck.
TITAN is now closed to recruitment..
PET-NECK (A multicentre randomised phase III trial comparing PET-CT guided watch and wait policy versus planned neck dissection for the management of locally advanced (N2/N3) nodal metastases in patients with head and neck squamous cancer)
PET-Neck is a study evaluating treatment for patients with large metastasis to the neck nodes. Current standard care is neck dissection either before/after chemoradiotherapy (CRT). There is debate regarding whether a neck dissection is needed or whether CRT alone is sufficient. The study will compare standard care, CRT and neck dissection, with CRT alone followed by PET-CT surveillance which will detect if there are cancer cells in the lymph nodes.
PET-NECK is now closed to recruitment.
The results have been published in The New England Journal of Medicine:
Mehanna H, Wong WL, McConkey C, Rahman JK, Robinson M, Hartley AG, Nutting C, Powell N, Al-Booz H, Robinson M, Junor E, Hulme C, Smith AF, Hall P, Dunn J. PETCT – guided surveillance versus planned neck dissection in advanced nodal disease of head and neck cancer treated by chemoradiotherapy. N Engl J Med. 2016 Apr 14;374(15):1444-54. DOI: 10.1056/NEJMoa1514493. Epub 2016 Mar 23. https://www.ncbi.nlm.nih.gov/pubmed/27007578