A trial looking at the size of the radiotherapy treatment area for people with soft tissue sarcoma (VORTEX)

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

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Closed

Phase:

Phase 3

This trial is looking at the size of the radiotherapy treatment area after surgery for soft tissue sarcoma. It is looking at treatment in people with soft tissue sarcoma of the arm, leg, hand or foot. This trial is supported by Cancer Research UK.

Some people with soft tissue sarcoma will have surgery to remove their sarcoma, then radiotherapy to the operation site. At the moment, doctors give large amounts of radiotherapy to the normal tissue surrounding the operation site, as well as the operation site. They think that this might reduce the risk of the sarcoma coming back. But there is not really any research to say that this is the case.

The aim of this trial is to find out if reducing the size of the radiotherapy treatment area and treating less of the normal tissue will cause fewer side effects, without increasing the risk of the sarcoma coming back.

Who can enter

You can enter this trial if you

Have been diagnosed with soft tissue sarcoma of your hand, arm, leg or foot and you are due to have surgery to remove your sarcoma
Are aged 16 years or older
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant

You cannot enter this trial if you

Have been diagnosed with one of the following
- A rhabdomyosarcoma of alveolar or embryonal type (your doctor will be able to tell you if this applies to you
- A primitive neuro ectodermal tumour (PNET)
- Soft tissue Ewings sarcoma
- Osteosarcoma which has started outside of the bones
- Desmoid tumours
- A kind of soft tissue sarcoma called dermatofibrosarcoma protruberans
- Gorlin’s syndrome
Had surgery to remove your sarcoma more than 3 months ago
Have already had radiotherapy treatment to your sarcoma
Have already had chemotherapy treatment for your sarcoma
Are aged under 16 years
Have or have had any other type of cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix which have been treated, or another cancer that has been in complete remission for at least 3 years

Trial design

This trial will recruit about 400 people with soft tissue sarcoma who are having radiotherapy after their surgery.

There are two treatment groups in this trial. The trial is randomised. After having surgery, the people taking part are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group one, you will have standard radiotherapy. If you are in group two, your radiotherapy treatment area will be slightly smaller.

People in both groups will have radiotherapy every day (Monday to Friday) for 6 weeks, then once a day for 3 days in week 7. This is 33 treatments in total.

Hospital visits

You will see the trial doctors and have some tests before your operation. the tests include

Blood tests
Chest X-ray
MRI scan
CT scan

After your operation, the doctor will check your operation site to make sure that it is healing and that you can start radiotherapy. And they will check that you wish to continue in the trial.

Before you start your radiotherapy, you will fill out two questionnaires. These will ask you questions about your quality of life and how it has been affected by your sarcoma and its treatment. You will complete these again

Every 3 months for the first 6 months
Every 6 months, up until 2 years after treatment

During your radiotherapy treatment you will see a doctor every week. They will examine your radiotherapy site, ask you how you are and ask if you have any side effects.

When you have finished treatment, you will continue to see a doctor as an outpatient. You will have a chest X-ray every 3 months for the first two years, every 6 months from year 2 to year 5, and then once a year after that. You will have a MRI scan after one year and two years.

Side effects

The side effects of your radiotherapy will depend on the area of your body being treated. Your doctor will talk to you in detail about what to expect. The most common side effects of radiotherapy include