A study looking at testing sentinel lymph nodes, radiotherapy and chemotherapy for vulval cancer (GROINSS-VII)

This study is looking at whether it is safe to have radiotherapy instead of surgery when vulval cancer has spread to the sentinel lymph nodes. The first treatment for vulval cancer is usually surgery. As well as removing the part of the vulva affected by cancer, the surgeon usually removes the lymph nodes from one or both groins. These lymph nodes are usually the first place where cancer cells can spread to. Removing them makes it less likely that the cancer will come back.

After surgery, women who have cancer cells in the lymph nodes may need to have additional treatment with radiotherapy. Sometimes you also have chemotherapy. Although combining surgery and radiotherapy may work well, it can cause side effects such as swelling in the legs (lymphoedema) and problems with wound healing.

In this study, researchers will find and test the lymph nodes nearest to the vulva. This is called sentinel node mapping. If there are no cancer cells in the sentinel node, you will not have any more treatment.

If there are cancer cells in the sentinel nodes, you will have radiotherapy. Some women taking part will also have chemotherapy. Doctors think that this will cause fewer side effects than the combination of surgery to remove all the lymph nodes followed by radiotherapy. But they need to find out if it is as good at stopping the cancer coming back.

The aims of the study are to

Learn more about sentinel node mapping
Find out if radiotherapy alone works as well as surgery (with or without radiotherapy) when the sentinel lymph nodes contain cancer cells
Learn more about the short term and long term side effects of vulval cancer treatment

Recruitment

Start 01/10/2008

End 31/01/2014

Phase

Other

Who can enter

You can enter this trial if you

Have been diagnosed with squamous cell carcinoma of the vulva
Have a tumour that is smaller than 4cm across but has grown at least 1mm into the skin

You cannot enter this trial if

Tests before your operation show that your cancer has definitely spread to the lymph nodes
You have cancer in more than one area of the vulva
Your cancer reaches your urethra, vagina or anus (your doctor will explain whether or not this applies to you)
You are pregnant or breast feeding

Trial design

This is an international study and will recruit women in a number of different countries. Everybody taking part will have surgery to remove vulval cancer and the sentinel lymph nodes.

To find the sentinel nodes, the doctor will use some local anaesthetic cream to numb the skin around the cancer. They will then inject a small amount of a radioactive marker into the area around the cancer. The dose of radioactivity is very low. Following the injection a special type of camera takes a number of pictures to show which lymph nodes the marker goes to first. These are the sentinel nodes. You may have this test done on the day of your operation, or the day before.

During your surgery, the surgeon will inject a blue dye around the cancer. This also helps them to find the sentinel lymph nodes. The surgeon only removes the sentinel nodes and sends them to the laboratory to be checked for cancer cells. Your surgeon will not remove all the lymph nodes. In the laboratory, the sentinel nodes will be looked at very carefully. It can take about 2 weeks to get the results.

If no cancer cells are found in the sentinel lymph nodes, you won’t have any more treatment. You will have follow up appointments with the trial team for the next two years.

If there are cancer cells in the sentinel nodes, you will have radiotherapy. This will start within 6 weeks of your surgery. You usually have radiotherapy everyday (Monday to Friday) for 4 to 5 weeks.

Some women may also have chemotherapy to make the cancer cells more sensitive to the radiotherapy. Doctors use a drug called cisplatin. You have it through a drip into a vein once a week during the 4 or 5 weeks of radiotherapy.

Hospital visits

You will see the doctors and have some tests before you join the study. The tests may include

Physical examination
CT scan or MRI scan
Ultrasound
Lymph node biopsies

You are likely to be in hospital for between 1 and 4 days to have surgery.

The researchers expect to find positive sentinel lymph nodes in only 2 or 3 out of every 10 women tested. These women will need radiotherapy. If you do have radiotherapy, you will go to hospital every day for 4 or 5 weeks. Each treatment only takes a few minutes. If you have chemotherapy as well, one hospital visit each week will be longer.

Everybody taking part in the study will have follow up appointments with the trial doctors every 2 months for 2 years.

Side effects

Your urine will be blue or green for a day after you have the blue dye. The dye may make your skin appear greyer than normal, but this will go off quickly.

Possible side effects of surgery to remove lymph nodes from your groin include