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.

Cancer type:

Cervical cancer

Status:

Closed

Phase:

Phase 2/3

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 external radiotherapy Open a glossary item. This is called image-guided bone marrow-sparing intensity modulated radiation therapy (IG-BMS-IMRT).

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 bone marrow Open a glossary item and nearby organs, for example the bladder. This could help to reduce side effects.

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 pelvis Open a glossary item, as you do for cervical cancer. Having a low number of blood cells could delay your treatment.

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 Open a glossary item

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.

Cancer related

  • You have already had chemotherapy
  • Your cancer has spread to lymph nodes Open a glossary item close 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

Medical conditions

  • You have had another cancer in the last 3 years apart from non melanoma skin cancer Open a glossary item that 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

Other

  • 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

Trial design

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

INTERTECC diagram

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.  

You have cisplatin chemotherapy once a week as a drip into a vein. You have up to 6 cycles of treatment.  

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

Hospital visits

You see a doctor and have some tests before taking part in the trial. These tests include:

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

Side effects

The most common side effects of radiotherapy include:

We have information on the side effects of:

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Alexandra Stewart  

Supported by

UC San Diego
National Cancer Institute (NCI)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10677

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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