A trial comparing radiotherapy 3 times a day with radiotherapy once a day for head and neck cancer (CH03)

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

Cancer type:

Head and neck cancers

Laryngeal cancer

Mouth and oropharyngeal cancer

Nasal and paranasal sinus cancer

Nasopharyngeal cancer

Pharyngeal cancer

Salivary gland cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at a new way of giving radiotherapy called CHARTWEL.

Radiotherapy is sometimes given after surgery for head and neck cancers. This is to try to stop the cancer coming back. This trial is comparing 2 different ways of giving radiotherapy to people at high or medium risk of a recurrence of their cancer. The trial is comparing radiotherapy 3 times a day (CHARTWEL) with once daily treatment (conventional radiotherapy). The trial is to see which type of radiotherapy is better at stopping the cancer from coming back. The study is also comparing the side effects.

Who can enter

You can enter this trial if

You have been diagnosed with a squamous cell cancer anywhere in your head or neck
Your surgery was intended to cure your cancer
Your doctor believes that there is either a high or intermediate chance of your cancer coming back if no further treatment is given
You can start your radiotherapy within 100 days of having your operation

You cannot enter this trial if you

There are signs of cancer spread any further than the lymph nodes in your neck
You have any medical condition that is not controlled
You have had another cancer in the past that could come back

Trial design

This trial is recruiting 460 patients over 3 years. There are 2 treatment groups. Group 1 will have radiotherapy 3 times a day, Monday to Friday for 2 weeks. This type of treatment is known as CHARTWEL. This stands for Continuous Hyperfractionated Accelerated Radio Therapy - Week End Less.

Group 2 will have radiotherapy once a day, Monday to Friday for 6 weeks. This is known as conventional radiotherapy.

The trial is randomised. The people taking part are put into the different treatment groups by a computer.

You will be asked to complete questionnaires occasionally about how you have felt for the previous week, your general health and any side effects. You will be asked to do this before the study and then yearly for 5 years.

Hospital visits

If you are having CHARTWEL, you will have to stay in hospital for 2* weeks (Mondays and Fridays) to have your treatment. Each day, you will have 3 treatments, 6 hours apart. If practical, you can go home over the weekends.

If you are having conventional radiotherapy, you will have to visit the hospital daily, between Monday and Friday for the 6 week treatment period.

You will be asked to go to hospital for check ups after your treatment is over. Both groups will be seen weekly until the 8th week since treatment began. You will then be seen

12 weeks after treatment started
Every 3 months until 2 years
Every 6 months until 5 years

You will be asked to have chest X-rays at the 12 week, 6 month and 1 year check ups.

Side effects

The side effects are similar for both types of treatment. Side effects during the treatment period may be slightly more severe for CHARTWEL, but should clear up more quickly than with conventional radiotherapy. Side effects during, and immediately after, treatment can include

Sore mouth and throat with pain and swelling
Hoarse voice
Difficulty swallowing
Tiredness
Sore skin

Long term side effects are similar. They can happen with either type of treatment. They can include

Husky voice
Dry mouth - you will produce less saliva (spit) and it may be thick and sticky - this can be permanent
Tooth decay is more likely because you have a dry mouth
Taste changes - this will gradually improve, but your taste may never be as sharp as before
Spinal cord damage causing leg weakness and numbness - this is extremely rare and not expected to happen to anyone in this trial