A trial looking at treatment after surgery for womb cancer (STATEC)

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

Cancer type:

Womb (uterine or endometrial) cancer

Status:

Closed

Phase:

Phase 3

This trial is for women with early stage womb cancer who have a high risk of their cancer coming back (recurring) after surgery.

Cancer Research UK supports this trial.

More about this trial

Surgery is the first treatment for women with early stage womb cancer. You have an operation to remove the womb, ovaries and fallopian tubes.

Further treatment after surgery is offered to reduce the risk of recurrence. This is called adjuvant treatment. The choice of adjuvant treatment can vary from hospital to hospital.

In some hospitals, the approach is for women to have an operation to remove their lymph glands Open a glossary item (also called nodes). This is called a lymphadenectomy. Further treatment then depends on whether cancer is found in the lymph glands or not.

Women who have cancer in the lymph glands have chemotherapy and radiotherapy. Women who do not have cancer in the lymph glands have internal radiotherapy only.

In other hospitals the approach is for women to have chemotherapy with or without radiotherapy. They do not have a lymphadenectomy.

Eight out of every 10 women (80%) who have their lymph glands removed are found to have no cancer in their lymph glands. So these women can avoid having chemotherapy and external radiotherapy. They will only have the possible side effects of internal radiotherapy.

The trial team think that having a lymphadenectomy to decide on further treatment might be as good at treating womb cancer with chemotherapy and possible radiotherapy (with no lymphadenectomy). The side effects and quality of life might also be improved for women with no cancer in their lymph nodes. But these approaches need to be compared in a trial.

The trial team will compare these 2 approaches to:

see how well they work for womb cancer
learn more about the side effects and quality of life

Sentinel lymph gland sub study
Part of this trial is also looking at the benefits of testing the sentinel lymph glands. The sentinel lymph glands are the lymph glands nearest to a body organ, such as the womb.

Any fluid draining from an organ reaches the sentinel lymph glands first. If cancer is going to spread, it is likely to spread to the sentinel lymph glands first.

At the moment, some hospitals use the sentinel lymph gland procedure to look for womb cancer spread. In this procedure about 4 to 8 sentinel lymph glands are removed. If these contain cancer, women have further surgery to remove more lymph glands. If the sentinel lymph glands don’t contain cancer, no more lymph glands are removed.

In other hospitals, women have a lymphadenectomy. You have about 20 to 30 lymph glands removed from your tummy and around your womb. These include both sentinel lymph glands and other lymph glands.

Doctors think testing the sentinel lymph glands might be as good as a lymphadenectomy. If so, a sentinel lymph gland procedure is a smaller, quicker operation. And it might have less side effects.

In this trial, those women who have their lymph glands removed have a lymphadenectomy. They have extra tests on their sentinel glands if they also agree to take part in the sub study. You won’t have any direct benefit from taking part, but it might help doctors to find out which way of testing the lymph glands is best.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this trial if all of the following apply.

You have womb cancer that has been confirmed with a tissue sample (biopsy )
Your doctor thinks your cancer has not spread, but might be growing into the wall of the womb (stage 1 womb cancer). Your stage will be confirmed after your operation to remove your cancer
You have a high risk of your cancer coming back (grade 3 or high grade)
You are due to have surgery to remove your womb cancer within 5 weeks of joining the trial. If you have already had this operation before joining this trial, you must have had your surgery in the last 4 weeks. If you are due to have a lymphadenectomy as part of this trial, you must have this within 5 weeks of joining the trial
You have not had any previous treatment for your womb cancer
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have satisfactory blood test results
You are at least 16 years old
You are able to have chemotherapy, with or without radiotherapy, following your operation. This should start within 2 months of your surgery

Who can’t take part
You cannot join this trial if any of these apply.

You have a type of womb cancer called small cell with features of a neuroendocrine tumour
Your lymph glands measure over 10mm on an x-ray or scan
You are currently having any other cancer treatment
You have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer , basal cell carcinoma, or melanoma in situ that was successfully treated
You are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need about 1000 women in the UK to take part.

It is a randomised trial. The women 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.

One group has surgery including a lymphadenectomy, the results help to decide further treatment
The other group has surgery (with no lymphadenectomy), followed by chemotherapy, with or without radiotherapy

STATEC trial diagram

Group 1
You have surgery to remove your:

womb and cervix (a hysterectomy)
ovaries and fallopian tubes (bilateral salpingo oophorectomy or BSO)

You also have lymph glands removed (lymphadenectomy) during the same operation. These are lymph glands from your tummy and around the womb. A pathologist Open a glossary item examines the lymph glands find out if they contain cancer.

If you have already had a hysterectomy before joining this trial, you have your lymph glands removed as a separate operation.

Your surgical team take photos of your operation site following removal of the lymph glands. They do this while you are still asleep under a general anaesthetic. The photos are part of this trial and are not routine care. They are stored on a secure database.

Another team of surgeons look at the photos to check the quality of the surgery.

You stay in hospital to have your operation for between 2 to 5 days. Exactly how long depends on the type of operation you have.

You see your doctor about 3 to 5 weeks after your operation to discuss further treatment. The type of treatment you have depends on whether cancer has spread to your lymph glands.

Cancer that has spread to the lymph glands is called node positive disease.
Cancer that has not spread to the lymph glands is called node negative disease.

For node positive cancer, you have chemotherapy with or without external radiotherapy. You might also have internal radiotherapy. Whether you have radiotherapy depends on the discussion you have with your doctor.

For node negative cancer, you have internal radiotherapy. You do not have chemotherapy or external radiotherapy

Group 1 – Sentinel lymph gland sub study
At the start of this trial you might be asked to take part in this sub study. But only women in group 1 go on to take part. Women in group 2 do not take part in the sub study.

Everyone in group 1 has their lymph glands removed in the same way. But as part of the sub study, you have some extra tests on the sentinel lymph glands.

You have a special dye injected into your cervix (neck of the womb). This dye helps to show up the sentinel lymph glands.

Different kinds of dye are used by different hospitals. You have the injection into your cervix only, or into the womb and cervix. You have the injection either before you have a general anaesthetic, or after you are asleep.

When and how you have your injection depends on the type of dye you have. The department staff will explain everything before you have your operation.

After your operation your lymph nodes are examined by the trial team. They compare the sentinel glands with the other lymph glands.

You don’t have to take part in this sub study if you don’t want to. If you decide not to, you can still take part in the main trial.

Group 2
You have surgery to remove your:

womb and cervix (a hysterectomy)
ovaries and fallopian tubes (bilateral salpingo oophorectomy or BSO)

You do not have your lymph glands removed. If you have already had this operation before joining the trial, you do not need another operation.

After your operation, you have chemotherapy with or without external radiotherapy. You might also have internal radiotherapy. Whether you have radiotherapy depends on the discussion you have with your doctor.

Chemotherapy
Your doctor explains which drugs you are going to have and how often. You usually have your chemotherapy through a drip into a vein every few weeks.

External beam radiotherapy
Your doctor explains how much external radiotherapy you are going to have.

You lay on a couch and radiation is directed at your cancer from a machine outside of the body.

You usually have treatment as an out patient every day, Monday to Friday. Each treatment only takes a few minutes. But you might be in hospital a bit longer if you have to wait for your treatment.

Internal radiotherapy (brachytherapy)
To have internal radiotherapy, you have a probe placed inside your vagina for about 30 minutes. This probe delivers the treatment. You have between 2 to 4 treatments over 1 or 2 weeks.

You usually have your brachytherapy as a day patient. You stay in hospital for a few hours each time.

Quality of Life
The trial team will ask you to fill out a questionnaire:

before you start treatment
when you have finished treatment after surgery
on 8 different occasions over the next 5 years

These questionnaires ask about your quality of life. They ask you about side effects and how you’ve been feeling.

Tumour and blood samples
To help the trial team understand more about womb cancer they will ask if they can have:

a sample of tissue removed during your hysterectomy
a sample of your lymph glands if you are in group 1
a blood sample before you start treatment

You don’t have to agree to provide these extra samples if you don’t want to. You can still take part in the main trial.

Hospital visits

You see the doctors and have some tests before you start treatment in this trial. These are routine tests you would normally have as part of your care:

blood tests
physical examination including examination of your vagina
an MRI scan or CT scan of your tummy and pelvis
general tests to record your height, weight and mobility

You might also have an ultrasound scan of your tummy and pelvis.

You see the doctor regularly as part of this trial for 5 years. Your hospital visits and tests are similar to those you would have anyway, as part of routine care. You don’t have any extra follow up visits as a result of being part of this trial.

You have appointments:

every 3 months for the first year
every 4 months in the second year
every 6 months in the third year
once a year in the fourth and fifth years

Your doctor will ask how you are and about any side effects. You might have some of the above tests repeated.

Side effects

The side effects of having a hysterectomy and bilateral salpingo oophorectomy include:

bleeding
infection
constipation
injury to the bladder, the tube that runs from the kidney to the bladder (ureter) or the bowel
blood clots in the legs (deep vein thrombosis)

We have more information about surgery for womb cancer.

The side effects of a lymphadenectomy include:

bleeding
a collection of fluid (cyst) in your tummy or pelvis that might need draining
numbness in thighs or weakness in legs due to nerve damage, this is usually temporary and gets better on its own

About 5 out of every 100 (5%) women develop long term problems with pain and swelling in their legs. This is called lymphoedema. You can have treatment to manage the symptoms of lymphoedema.

Read about cancer and lymphoedema.

We also have information about