A trial of radiotherapy with different doses of chemotherapy for head and neck cancers

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer

Status:

Results

Phase:

Phase 1

This trial was trying to find the best dose of chemotherapy to give with radiotherapy for squamous cell cancers of the head and neck.

Many head and neck cancers are squamous cell cancers. Squamous cells are the flat, skin like cells that cover the inside of the mouth, nose, voice box (larynx) and throat.

Doctors usually treat head and neck squamous cell cancer with radiotherapy and chemotherapy, given at the same time. We knew from research that having chemotherapy and radiotherapy together worked better than radiotherapy alone. But doctors were less sure about the best dose of chemotherapy to use. In this trial, they were trying to work out the best and safest dose of a chemotherapy drug called carboplatin.

The aims of the trial were to

  • Find the best dose of carboplatin to have with radiotherapy for squamous cell cancer of the head and neck
  • Learn more about the side effects

Summary of results

The trial team found a dose of carboplatin to have with radiotherapy that did not cause too many side effects.

The trial recruited 19 people who had squamous cell cancer of the head or neck.

Everybody taking part had radiotherapy for 4 weeks. And they had 2 doses of carboplatin - one in the 1st week of treatment and one in the 3rd week.

The first 3 people had a low dose of carboplatin. As they didn’t have any serious side effects, the next few people had a higher dose, and so on for 4 doses. At least 3 people safely had each dose before the dose was increased. The trial team found that the 3rd dose they tested was the highest they could give without causing bad side effects.

The side effects that people did have included a drop in the number of blood cells, skin reactions, and a sore mouth. Two people could not have the 2nd dose of chemotherapy because they had bad sickness after the 1st dose.

  • In 16 people, the cancer completely disappeared – researchers call this a complete response
  • In 1 person, the cancer had got smaller – researchers call this a partial response
  • In 2 people, the cancer got bigger

The trial team monitored the people taking part to see how they did. They found that 2 years after treatment

  • In 13 people, there was no sign of the cancer coming back
  • In 3 people, the cancer had come back in the same place as where it first started
  • In 2 people, the cancer had come back somewhere else in the body
  • In 1 person, the cancer had come back where it first started and somewhere else in the body

The cancer didn't come back in any other patients after 2 years.

After an average of more than 5 years of follow up, 9 of the 19 people who took part in the trial were living without any sign of the cancer having come back.

The researchers wanted to see if there were any long term side effects.  They found

  • 1 person had a breakdown of bone tissue in the jaw (osteoradionecrosis)
  • 1 person had problems eating and needed to have a feeding tube
  • 1 person had needed a small operation to widen the food pipe. This is called a dilatation. The food pipe (oesophagus) had become narrower due to the radiotherapy and this operation allowed them to swallow normally again
  • The other 6 people have not had any long term side effects so far

The trial team found a safe dose of carboplatin to have with radiotherapy. And they found that the cancer responded to treatment in most of people in this trial. Sadly some of the people who took part in this trial have since died.  But nearly half the people who took part are living without any sign of the cancer having come back more than 5 years after treatment.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. The figures we quote above were provided by the trial team. 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 J Glaholm

Supported by

Queen Elizabeth Hospital Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 298

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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