A trial looking at chemotherapy after surgery for cancer of the womb (EORTC 55102)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at having chemotherapy after surgery to remove womb (endometrial) cancer.
More about this trial
Doctors treat womb (endometrial) cancer with surgery. If the cancer hasn’t spread, you will see your specialist in the clinic at the hospital for 5 years. But unfortunately sometimes the cancer can come back.
We know from research that having chemotherapy after surgery to remove cancer can stop, or delay it, from coming back. The researchers want to find out if giving chemotherapy after surgery can help women whose womb cancer hasn’t spread.
To do this half the women in this trial will have carboplatin and paclitaxel chemotherapy after surgery. And the other half won’t.
The aims of this trial are to compare these 2 groups and find out
- How long women live overall
- How long they are alive and free of cancer
- What the side effects are
- What their
quality of life 
is
Who can enter
You may be able to join this trial if you are in one of the following situations. You have womb cancer that is
- Stage 1 or stage 2 endometrioid type (if it is stage 1, it must be
grade 3) - Stage 1 or stage 2 clear cell, serous, squamous cell or undifferentiated type
You must also
- Have had your womb and ovaries removed
- Have had at least 12
lymph nodes removed and there must be no cancer cells in your lymph nodes (your doctor can tell you this) - Have had surgery within the last 10 weeks
- Have satisfactory blood tests
- Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Be at least 18 years old
You cannot join this trial if any of these apply. You
- Have had any anticancer treatment apart from surgery
- Have another cancer apart from successfully treated in situ carcinoma of the cervix or basal cell skin cancer
- Have an infection
- Have another medical condition that could affect you taking part in this trial
Trial design
This is an international phase 3 trial. The researchers need 678 women to join.
It is a randomised trial. 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. And neither of you will know which group you are in.
- Women in group 1 will have surgery only (
standard treatment ) - Women in group 2 will have surgery then carboplatin and paclitaxel chemotherapy
You start chemotherapy within 3 months after your surgery. You have the chemotherapy as an injection into a vein every 3 weeks. You have a total of 6 treatments.
The trial team will ask you to fill out a questionnaire at the start of the trial, every 3 months for 2 years and then every 6 months for another 3 years. Women who had chemotherapy will fill in an extra questionnaire after their 4th treatment and when they finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery. If you don’t want to give this sample for research, you don’t have to. You can still take part in the trial.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- CT scan
During chemotherapy you see the doctor every 3 weeks for blood tests and to see how you are.
Everyone sees the doctor every 3 months for 2 years and then every 6 months for another 3 years.
Side effects
The most common side effects of carboplatin and paclitaxel are
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Tiredness
- Hair loss
- Flu like symptoms
- Tingling and numbness of your fingers or toes
- Joint pain
- Allergic reaction
We have information on carboplatin and paclitaxel
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Nick Reed
Supported by
Danish Gynaecologic Cancer Group (DGCG)
European Network of Gynaecological Oncology Trials groups (ENGOT)
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
