Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of anastrozole for hormone receptor positive gynaecological cancers (PARAGON)
We know that this is an especially worrying time for people with cancer and their family and friends. We have separate information about coronavirus and cancer. Please read that information alongside this page. We will update that information as guidance changes.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
Some cancer cells need hormones to grow. If the amount of hormone reaching the cancer cell is blocked then the cancer may stop growing. Hormone therapy can block hormones reaching hormone
In this trial doctors are looking at a hormone therapy drug called anastrozole. The aims of trial are to
- Find out if anastrozole helps women with hormone receptor positive gynaecological cancer
- Learn more about the side effects
Who can enter
You may be able to enter this trial if
- You have womb (endometrial) cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, sarcoma of the womb or cervix, granulosa cell tumour of the ovary or sex cord stromal tumour that has come back after treatment or has spread to another part of the body
- Your cancer is hormone receptor positive and can be measured on a scan or with a blood test
- You have permanently stopped having periods (are post menopausal)
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You cannot enter this trial if you
- Have already had an aromatase inhibitor, tamoxifen or progesterone to treat your gynaecological cancer
- Are taking
hormone replacement therapy (HRT)or only stopped taking it in the last 4 weeks
- Have had any other cancer in the last 5 years unless your doctors think there is no risk of it coming back
- Have certain problems with your liver or kidneys
This trial will recruit 350 women from around the world.
Everybody taking part takes an anastrozole tablet once a day. As long as you don't have any bad side effects, you can take anastrozole for as long as it helps you.
The trial team will ask you to fill out a questionnaire
- Before you start treatment
- Once a month for 3 months
- Then every 3 months until you stop treatment
The questionnaire will ask about side effects and how you have been feeling. This is called a quality of life study.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
- Bone density scan (
You see the trial team for blood tests once a month for 3 months. Then you see the trial team for blood tests and a CT scan every 3 months. You have a bone density scan every 1 or 2 years. You continue with these tests until your cancer starts to grow again.
The most common side effects of anastrozole are
- Hot flushes
- Dryness of the vagina
- Painful joints
- Tiredness (fatigue)
- Feeling or being sick
- Mood changes
- Loss of bone density which can increase the risk of bones breaking
- Hair thinning
- Skin rash
How to join a clinical trial
Dr Richard Edmondson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
University of Glasgow
This is Cancer Research UK trial number CRUK/10/056