A study of an increased dose of intensity modulated radiotherapy to treat head and neck cancer (ArChIMEDEs-Op)

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Cancer type:

Head and neck cancers
Mouth (oral) cancer

Status:

Results

Phase:

Other

This study looked at an increased dose of intensity modulated radiotherapy (IMRT) to treat cancer where the mouth joins the throat (the oropharynx).

Doctors call this oropharyngeal cancer. This study was for people whose oropharyngeal cancer wasn’t linked to the human papilloma virus (HPV Open a glossary item)

This study was open for people to join between 2012 and 2014. These results were published in 2018. 

More about this trial

Doctors can treat oropharyngeal cancer with a combination of chemotherapy and radiotherapy (chemoradiation). But standard chemoradiation doesn’t work so well in cancers that aren’t linked to HPV. So doctors are always looking for ways to improve treatment for these people.

They thought that intensity modulated radiotherapy (IMRT Open a glossary item) could improve treatment. 

The aim of this study was to see if it was safe and possible to give a 5 week course of radiotherapy at an increased dose (IMRT) with standard dose chemotherapy to treat oropharyngeal cancer that isn’t linked to HPV.

Summary of results

The team found that a 5 week course of radiotherapy with chemotherapy was an acceptable treatment for people with oropharyngeal cancer that wasn’t linked to HPV.

About this study
This was a feasibility study. 15 people joined the study. Everyone had 5 weeks of radiotherapy with either cisplatin or carboplatin chemotherapy. 

Results
Everyone completed all their radiotherapy.

3 months after treatment the team looked at what side effects people had and how severe they were. 

Their main interest was in how the radiotherapy affected the mouth. They looked at the number of people who had a severe inflamed mouth (mucositis Open a glossary item). 

At 3 months, 9 people had mucositis but no one had severe mucositis. Other side effects people had 3 months after treatment were:

  • skin problems caused by radiotherapy
  • discomfort or difficulty swallowing
  • tiredness (fatigue) caused by radiotherapy 

There were no very severe side effects from radiotherapy. One person had a severe side effect from cisplatin. They had carboplatin for the rest of their treatment. 

The team looked at how well the treatment had worked. 3 months after treatment finished they found that everyone had no sign of their cancer (complete response). 

The team were able to follow up everyone for at least 2 years after treatment. At 2 years the number of people who were alive was 14 (93%). 

After 2 years they looked at the late side effects from treatment. The worst side effects included:

  • problems with the inner ear and hearing
  • weight loss
  • dry mouth
  • inflammation of the tissue covering the mouth, nose, throat, food pipe, gut and bowel 
  • problems with their salivary glands for example less saliva being produced 

Conclusion
The study team concluded that 5 weeks of chemoradiotherapy is acceptable for people with oropharyngeal cancer. This treatment plan is now a part of a larger randomised control trial (CompARE).  The CompARE Trial is looking at how well this approach works compared to standard therapies and other approaches. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
 

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

Dr Paul Sanghera

Supported by

Queen Elizabeth Hospital Birmingham Charities
University Hospital Birmingham NHS Foundation Trust

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Last review date

CRUK internal database number:

9308

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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