A trial looking at radiotherapy or endoscopic surgery for early stage cancer of the glottis (EaStER)

Please note this trial is no longer recruiting patients.

This trial is to see if endoscopic surgery is as good as radiotherapy at stopping early stage cancer of the glottis coming back.

The glottis is the area around the vocal cords. It is part of the larynx. Patients with cancer of the glottis (glottic cancer) often have radiotherapy or surgery.

Traditionally, surgery for glottic cancer is ‘open surgery’ and involves making a cut in the skin. It can mean a lengthy recovery. Another option is to do the operation by passing a tube (an endoscope) through the mouth and into the throat. The surgeon then uses either surgical instruments or laser to remove the cancer. This is called endoscopic surgery, or endoscopic excision.

Open surgery is used less often in the UK now, and endoscopic surgery is becoming more popular. But no one has done a trial to show if endoscopic surgery is as good as radiotherapy. In this trial, some patients will have endoscopic surgery and some will have radiotherapy. The results of both groups will be compared to find out if endoscopic surgery is as good as radiotherapy at stopping the cancer from coming back (recurring).

This trial will also look at voice quality to find out if there is any difference in people’s voices following these two treatments’.

Please note, you cannot volunteer for this trial. If you are a patient at one of the hospitals involved and are eligible to take part, a member of the research team will contact you.

Recruitment

Start 01/09/2005

End 31/01/2009

Phase

Pilot

Who can enter

You can enter this trial if you

Have recently been diagnosed with squamous cell cancer of the glottis that has not spread to another part of the body
Are able to have an endoscopy
Are well enough for treatment
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to the lymph nodes or any other part of the body (metastasised)
Are due to have treatment aimed at controlling your symptoms rather than curing your cancer
Are having chemotherapy
Have had any other cancer in the last 10 years, apart from basal cell skin cancer or carcinoma in situ of the cervix that was treated successfully
Have any other serious medical condition
Are pregnant

Trial design

This is a randomised trial. There are 2 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

To begin with this trial will recruit 50 patients. If the results are promising, it will go on to recruit 656 patients.

If you are in group 1 you will have radiotherapy. You have treatment once a day, Monday to Friday, for 3 to 4 weeks.

If you are in group 2, you will have endoscopic surgery. You will have a general anaesthetic. The doctor will pass an endoscope through your mouth and into your throat. They will then remove the cancer using either surgical instruments passed through the endoscope, or a laser. The operation takes between 1 and 3 hours.

You will fill out a number of questionnaires as part of this trial. These will ask you about the quality and strength of your voice, about how you are feeling and about any side effects you have had. This will help the research team decide which treatment gives patients the best quality of life.