A trial looking at side effects of treatment for throat cancer (De-ESCALaTE HPV)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Head and neck cancers
Mouth (oral) cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at the side effects of treatment for people who have cancer of the part of the throat just behind the mouth (oropharyngeal cancer). It is looking at people who have oropharyngeal cancer and human papilloma virus. This trial is supported by Cancer Research UK.

More about this trial

Doctors usually treat oropharyngeal cancers by giving the chemotherapy drug cisplatin at the same time as radiotherapy. This is called chemoradiation.

Cetuximab is a biological therapy called a monoclonal antibody. We know from research that treating oropharyngeal cancers with cetuximab chemoradiation may be better than cisplatin chemoradiation and that the side effects may be reduced.

The human papilloma virus (HPV) causes a number of oropharyngeal cancers. The researchers want to find out if the side effects of treating these oropharyngeal cancers with cetuximab chemoradiation are better for patients than treating them with cisplatin chemoradiation.

Who can enter

You may be able to enter this trial if

  • You have squamous cell carcinoma of the oropharynx
  • Your cancer has spread to between 1 and 3 lymph nodes – if your lymph nodes aren’t affected and your cancer has spread you may still be able to take part
  • You are to have cisplatin chemoradiation
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 6 months afterwards
  • You are at least 18 years old

You cannot enter this trial if

  • Your cancer has spread to another part of your body – apart from nearby tissue
  • Your cancer has spread to 1 or more lymph nodes on the side of your neck and these are 6cm or bigger (or spread to 2 or more smaller lymph nodes), you have HPV and you smoke more than a certain amount per year – your doctor can advise about this
  • You have a serious heart problem
  • You have serious hearing problems
  • You have had another cancer in the past 3 years apart from basal cell skin cancer and carcinoma in situ of the cervix
  • You have any other medical condition that could affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. After agreeing to take part in the trial the researchers will test your cancer for the human papilloma virus (HPV). The trial will recruit 304 people whose cancer tested positive.

This is a randomised trial for people whose cancer tested positive for HPV. You are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in group 1 have cisplatin and radiotherapy. You have cisplatin as a drip into a vein every 3 weeks for 7 weeks. You have radiotherapy for 7 weeks.

People in group 2 have cetuximab and radiotherapy. You have cetuximab weekly as a drip into a vein for 8 weeks, starting a week before radiotherapy. You have radiotherapy for 7 weeks.

Please note people who tested negative for HPV can no longer take part in the trial.

The trial team will ask you to fill out a questionnaire before you start treatment, at the end of treatment then at 3 months, 6 months, 1 year and 2 years after your treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

You will also be asked to complete an additional questionnaire before you start treatment, at the end of treatment then at 6 months, 1 year and 2 years after your treatment. The questionnaire asks about how your disease and its treatment affect your finances (for example, if there is more cost because of additional hospital visits). This is called a resource use questionnaire.

If you agree to take part in this trial, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. They will also ask for some spit samples and extra blood samples before you start treatment and after treatment. If you don’t want to give these samples you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

During treatment you see the doctor weekly for a blood test and to see how you are.

After treatment you see the doctor regularly for 2 years.

Side effects

The most common side effects of cisplatin are

The most common side effects of cetuximab are

  • Skin rash
  • Feeling or being sick
  • Tiredness
  • Infection
  • Difficulty swallowing
  • Sore, dry  mouth

Your doctor will talk to you about the possible side effects of the treatments before you agree to take part in this trial.

We have information about the side effects of radiotherapy for head and neck cancer in our head and neck radiotherapy side effects section. We also have more information about cisplatin and cetuximab in our cancer drugs section.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Hisham Mehanna

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
University of Warwick
Warwick Medical School Clinical Trials Unit

Other information

This is Cancer Research UK trial number CRUK/11/043.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

7400

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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