Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of chemotherapy before chemoradiation for cervical cancer (INTERLACE)
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This trial is looking at having carboplatin and paclitaxel chemotherapy before chemoradiation for cervical cancer that cannot be removed with surgery. This trial is supported by Cancer Research UK.
Doctors often treat cervical cancer with a combination of radiotherapy and a chemotherapy drug called cisplatin. This treatment is called chemoradiation and is
The aim of this trial is to see if having chemotherapy for 6 weeks before standard chemoradiation is better than chemoradiation alone for women with cervical cancer that cannot be removed with surgery.
Who can enter
You may be able to enter this trial if
- You have cervical cancer that is larger than 4cm across (stage 1B2 to stage 4A), or 4cm or less (stage 1B1) if the cancer is also in the lymph nodes
- Your doctors think chemoradiation is the best treatment for you
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are at least 18 years old
- You are willing to use reliable contraception during the trial if there is any chance you could become pregnant
You cannot enter this trial if you
- Have cancer spread to the lower third of the vagina (stage 3A)
- Have cancer that has spread to other parts of your body (stage 4B)
- Have cancer that is blocking one of the tubes between your kidneys and your bladder (the ureters) which has made the kidney waterlogged (hydronephrosis) – you may be able to take part if this has been successfully treated
- Have had another cancer in the last 10 years apart from basal cell skin cancer
- Have ever had another cancer in the area between your hip bones (the
- Have already had radiotherapy to your pelvis
- Have bowel conditions called Crohn’s disease or ulcerative colitis
- Have certain heart problems – the trial team can advise you about this
- Are HIV positive or have tuberculosis (TB)
- Are pregnant or breastfeeding
This phase 3 trial will recruit nearly 500 women. 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.
Half the women taking part have standard chemoradiation. The other half have chemotherapy on its own before chemoradiation. This is called induction chemotherapy.
If you are in the induction chemotherapy group, you have the drugs carboplatin and paclitaxel once a week for 6 weeks before you start chemoradiation. You have both drugs through a drip into a vein.
External radiotherapy uses radiation from a machine outside your body. Internal radiotherapy means a radioactive source is put into your vagina and up into the womb. Your doctor will give you more information about your radiotherapy plan and exactly how many treatments you will have. During radiotherapy, you also have the chemotherapy drug cisplatin once a week for 5 weeks. You have it through a drip into a vein.
The trial team will ask you to fill out a questionnaire before you start treatment, once during treatment and at follow up appointments after your treatment. If you have the induction chemotherapy you will also be given a questionnaire to fill out during chemotherapy. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will also ask your permission to get a sample of tissue that was removed when your cancer was diagnosed. Researchers will use this to learn more about cervical cancer and to see if there are ways of working out who might benefit from particular treatments.
You see the trial doctors and have some tests before you start treatment. The tests include
During chemoradiation, you go to hospital once a day (Monday to Friday) for up to 6 weeks. When you have internal radiotherapy, you may need to stay in hospital overnight.
If you are in the induction chemotherapy group, you have at least 6 extra hospital visits. You will be at the hospital for about half the day each time.
During treatment, you have regular blood tests and physical examinations. About 4 weeks after you finish treatment, you see the trial doctors and have more blood tests. You have an MRI or CT scan 3 months after the end of your treatment.
You see the trial team every 3 months for 2 years and then every 6 months for the next 3 years. At each of these follow up appointments, the trial team will ask you to fill out a quality of life questionnaire.
The side effects of the chemotherapy drugs in this trial include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Constipation or diarrhoea
- Skin rash
- Tiredness (fatigue)
- Hair loss
- Aching joints or muscles
- Tingling in your hands and feet (peripheral neuropathy)
- Damage to your kidneys
Radiotherapy also causes side effects. If you are still having periods, you will go through the
We have more information about the side effects of radiotherapy for cervical cancer in our cervical cancer section. There is more information about carboplatin, paclitaxel and cisplatin in our cancer drugs section.
How to join a clinical trial
Dr Mary McCormack
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Gynecologic Cancer InterGroup
NIHR Clinical Research Network: Cancer
National Cancer Research Institute (NCRI)
University College London (UCL)
This is Cancer Research UK trial number CRUK/11/024.
For more information you can watch 3 videos from the INTERLACE trial team. The first video tells you about the background of the trial. In the second video one of the trial doctors and nurse talk about who can enter and what the trial involves. And the final video two patients talk about their experinece of the trial.