A trial looking at radiotherapy and chemotherapy after surgery in women with womb (endometrial) cancer (PORTEC 3)

This trial is comparing radiotherapy on its own with radiotherapy and chemotherapy in women with womb (endometrial) cancer.

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 pelvis can help to stop cancer coming back in that area of the body. But it can’t stop cancer coming back elsewhere in the body.

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

Recruitment

Start 30/04/2009

End 30/04/2014

Phase

Phase 3

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)

Trial design

This is a randomised trial. It will recruit about 500 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 cervix.

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

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

Physical examination
Blood tests
Chest X-ray
CT scan

If you are to have chemotherapy, you may also have

A heart trace (ECG)
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.

Side effects

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