“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at radiotherapy and chemotherapy after surgery in women with womb (endometrial) cancer (PORTEC 3)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing radiotherapy on its own with radiotherapy and chemotherapy in women with womb (endometrial) cancer. This trial is supported by Cancer Research UK.
Doctors usually treat womb cancer with surgery. Some women have radiotherapy after surgery, especially if there is a high risk that the cancer will come back. They may have a high grade cancer, for example.
Radiotherapy to the
Doctors think that chemotherapy during and after radiotherapy will help stop cancer coming back in another part of the body. But they do not know this for certain. All chemotherapy drugs have side effects, and so it is important that patients do not have treatments that don’t work.
The aims of this trial are to
- Find out if it is better to have radiotherapy and chemotherapy after surgery for womb cancer than radiotherapy on its own
- Learn more about the side effects of these treatments and how they affect quality of life
Who can enter
You can enter this trial if you
- Have been diagnosed with cancer of the womb
- Have cancer that is stage 1 and is at high risk of coming back (grade 3), or is stage 2, or stage 3 (your doctor can tell you more about this)
- Have had surgery to remove your womb and both ovaries (total abdominal hysterectomy and bilateral salpingo-oophorectomy) - you may be able to take part if you have had keyhole (laparoscopic) surgery, but if you have had a radical (Wertheim) hysterectomy for stage 2 womb cancer, you may not be able to take part - the trial doctors can advise you about this
- Are due to have radiotherapy
- Are well enough to take part (performance status 0,1 or 2)
- Have satisfactory blood test results
You cannot enter this trial if you
- Have a type of cancer affecting the womb called sarcoma
- Have had radiotherapy to the pelvis before
- Have had hormone treatment or chemotherapy for your womb cancer
- Had any cancer left behind after your surgery
- Have any medical problems that affect how well your heart is working
- Have damage to the nerves in your hands and feet (
peripheral neuropathy) - unless it is mild
- Are deaf or have hearing problems
- Have a bowel condition such as Crohn’s disease or ulcerative colitis
- Have had any other type of cancer in the last 10 years (except for non melanoma skin cancer)
This is a randomised trial. It will recruit about 670 women into 2 groups. 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.
Group 1 will have external radiotherapy to the pelvis. Group 2 will have external radiotherapy and chemotherapy together (chemoradiotherapy) followed by more chemotherapy.
If you are in group 1, you have radiotherapy once a day, 5 days a week for about 6 weeks. You may also have internal radiotherapy if there are any cancer cells in your
If you are in group 2, you have radiotherapy as above. But you will also have cisplatin chemotherapy on the day you start radiotherapy and again 3 weeks later. You have this through a drip into a vein over 2 hours. You will need to have extra fluid before and after the cisplatin.
Within 3 weeks of finishing radiotherapy and as long as you have recovered from any side effects from the chemoradiotherapy, you will start paclitaxel (Taxol) and carboplatin chemotherapy. You have this once every 3 weeks for about 3 months. It will take about 4 hours to have both drugs.
Your doctor will ask you to fill out a questionnaire about how you have been feeling. This is called a quality of life questionnaire. You do this
- Before treatment starts
- When radiotherapy (and chemotherapy) finishes
- Every 6 months for the first 2 years
- Then once 3 and 5 years after treatment
You will see the doctors and have some tests before you can take part in this trial. The tests include
If you are to have chemotherapy, you may also have
- A heart trace (
- Hearing tests
You will go to the hospital for radiotherapy every weekday for 5 to 6 weeks.
If you are in group 2, you have 4 extra trips to the hospital to have chemotherapy after your radiotherapy. You will have blood tests every 3 weeks while you are having chemotherapy.
You will see the doctors for follow up
- Every 3 months for the first 2 years
- Every 6 months for the following 5 years
- Then once 7 and 10 years after treatment
You will have a physical examination at each visit, and a chest X-ray and blood tests once a year.
The side effects of the chemotherapy drugs used in this trial are
- A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
- Feeling or being sick
- Hair loss
- Tiredness (fatigue)
- Numbness and tingling (peripheral neuropathy)
- Hearing and kidney problems (with cisplatin and carboplatin)
The most common side effects of pelvic radiotherapy are
- Feeling sick
- Tummy pain and diarrhoea
- Bladder irritation (radiation cystitis)
- Sore skin
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.
Dr M. Powell
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/08/001.