"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of intensity modulated radiation therapy for cervical cancer (INTERTECC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find out more about a radiotherapy technique called intensity modulated radiation therapy (IMRT) alongside chemotherapy. It is for women whose cancer has not spread to distant parts of the body.
More about this trial
Chemoradiotherapy is one of the usual treatments for cervical cancer. Radiotherapy has improved in recent years and for some cancers it is possible to shape the beam to the exact treatment area. So you might have fewer side effects. This technique is called intensity modulated radiotherapy (IMRT).
In this trial, researchers are looking at a new way of planning IMRT to see if it causes fewer side effects than the usual
The researchers think that a scan called a PET-CT can help get better pictures of the area to be treated. This means the doctors could limit radiotherapy to the
One of the side effects the researchers are looking at in detail, is a drop in the number of blood cells. Radiotherapy can affect the cells in the bone marrow that produce your blood cells. This is more likely if you are having treatment to the
The aims of the trial are to find out:
- how well IMRT works for cervical cancer
- if IMRT reduces side effects compared with usual radiotherapy
- more about how the treatment affects
quality of life
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have cervical cancer that is still in the tissues of the cervix or has grown into surrounding tissues and pelvic organs, but has not spread to other parts of the body (anywhere between stage 1B to stage 4A)
- Are suitable to have radiotherapy to the area between your hip bones (pelvis) alongside chemotherapy
- Have had a CT, MRI or PET scan within 42 days of joining the trial
- Might need help from time to time but are well enough to look after yourself most of the time (Karnofsy performance 60-100)
- Have satisfactory blood test results
- Are willing to use reliable contraception if there is any chance you could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply.
- You have already had chemotherapy
- Your cancer has spread to
lymph nodesclose to nearby arteries, to lymph nodes in the groin or to distant parts of the body
- You are having chemoradiotherapy before surgery
- You have had radiotherapy to the pelvis or tummy (abdomen) in the past that means the radiotherapy areas would overlap
- You have had another cancer in the last 3 years apart from
non melanoma skin cancerthat was successfully treated
- You have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled or congestive heart failure
- You have diabetes that is not well controlled
- Your liver isn’t working properly – for example you have jaundice
- You have a severe lung condition called chronic obstructive pulmonary disease
- You have an infection that isn’t controlled and need antibiotics at the time of joining the trial
- You have HIV unless your blood counts are stable
- You have a hip replacement or any device fitted in your pelvis, sacrum or lower spine
- You are allergic to the contrast dye used for CT scans
- You are pregnant or breastfeeding
This is a phase 2/3 international trial. The researchers need 415 people including 100 from the UK to take part.
It is a randomised trial. You are put into 1 of 2 treatment groups. Neither you nor your doctor will be able to decide which group you are in.
- One group have IMRT and chemotherapy
- The other group have usual radiotherapy and chemotherapy
Everyone goes to the radiotherapy department for radiotherapy planning before starting treatment.
You have radiotherapy everyday, Monday to Friday, for 5 ½ weeks. This takes about 20 to 30 minutes each time.
Quality of life
You complete a few short questionnaires before you start treatment, at set times during treatment and after it finishes. The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see a doctor and have some tests before taking part in the trial. These tests include:
- a physical examination
- a CT scan or MRI scan of the area between your hip bones (pelvis)
- an x-ray or CT or PET-CT scan of your chest
- blood tests
As part of your radiotherapy planning, depending on what treatment group you are in you will have:
- a CT scan or PET-CT scan
- an MRI scan of your pelvis or a PET-CT scan
You go to hospital to have treatment. You shouldn’t need to stay overnight. You see the doctor once a week for a check up and blood tests during treatment and 1 month after finishing.
You have a PET-CT scan 3 to 4 months after your last treatment
After finishing treatment you have a check up and the doctors repeat some of the tests you had when you joined the trial. This happens at
- 6 months
- 1 year
- 2 years
- 3 years
How to join a clinical trial
UC San Diego
National Cancer Institute (NCI)