A trial looking at pazopanib with radiotherapy for people with soft tissue sarcoma (PASART 2)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Closed

Phase:

Phase 2

This trial is for people with soft tissue sarcoma that hasn’t spread and who are going to have treatment with radiotherapy and then surgery.

It is for people going to The Royal Marsden Hospital in London.

More about this trial

Soft tissue sarcoma is a cancer that starts in the supporting tissues of the body (the soft tissue) such as:

fat
muscle
blood vessels

There are different ways to treat soft tissue sarcoma that hasn’t spread. Often people have radiotherapy and then surgery.

Radiotherapy before surgery is called neoadjuvant radiotherapy. This shrinks the cancer so that it’s easier to remove during surgery. This is standard treatment Open a glossary item .

Pazopanib (Votrient) is a type of targeted therapy (biological therapy). It blocks a protein called tyrosine kinase that tells cells to divide and grow. Blocking this protein might stop cancer cells from growing.

Pazopanib is already used to help people with soft tissue sarcoma that has come back (recurrent soft tissue sarcoma). Now doctors want to find out if it can also help people with soft tissue sarcoma that hasn’t spread.

The main aims of this trial are to:

find out how well pazopanib and radiotherapy work as a treatment
learn about the side effects of treatment
find out what happens to pazopanib (pharmacokinetics) and the effects it has in the body (pharmacodynamics)
see if an MRI scan can be used to tell how well treatment works (response to treatment)

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 been diagnosed with soft tissue sarcoma and your doctor thinks that radiotherapy and then surgery is the best treatment for it
You are able to swallow and absorb tablets
You have satisfactory blood tests results
Your heart is working well
You are at least 18 years old
You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility you or your partner could become pregnant

You cannot join this trial if any of these apply.

Cancer related

You have soft tissue sarcoma that has come back (recurrent soft tissue sarcoma)
You have Ewing’s sarcoma, a primitive neuro ectodermal tumour (PNET ), rhabdomyosarcoma or osteosarcoma
You have had radiotherapy or chemotherapy in the past 2 weeks
You have had a biological therapy or an experimental treatment in the past month
You have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer or an early cancer (carcinoma in situ )

Medical conditions

You have problems with your digestive system such as inflammatory bowel disease, colitis, a peptic ulcer or any other condition that makes you at risk of having a hole in your bowel or stomach (perforation)
You have had an operation to remove part of your stomach or bowel (resection)
You have had a fistula , a hole (perforation) or an abscess in your tummy in the past 28 day
You have heart problems such as high blood pressure that is not controlled by medication, congestive heart failure that is causing you symptoms, angina that is not controlled or you have had a heart attack in the past 6 months
You have had an operation to put a stent in your heart or a coronary artery bypass graft (CABG) in the last 6 months
You have a build up of fat in your veins (peripheral vascular disease) that is causing you symptoms or you have had a blood clot in a large vein of your lungs in the past 6 months
You have a break in a bone (fracture) or a wound that hasn’t healed
You have had a large operation or injury (trauma) in the past month
You have had blood in your urine (haematuria) or you have coughed up blood (haemoptysis) is the past 4 weeks
You are bleeding or have a high risk of it (bleeding diathesis)
You have an infection that needs treatment that reaches your whole body (systemic treatment)
You have taken drugs that affect body substances called CYP enzymes in the past 2 weeks
You have another medical condition or mental health problem that the trial team think could affect you taking part

Other

You are sensitive to pazopanib or any other similar drug
You are not able to have an MRI scan for any reason, for example you have metal implants such as a pacemaker, surgical clips, implants, pins, plates, you have a fear of being in closed spaces (claustrophobia) or you are allergic to the dye (contrast medium ) given during the scan
You are not able to have samples of tissue (biopsy ) taken for any reason
You are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. Researchers need about 30 people to take part worldwide and hope that around 20 people going to The Royal Marsden Hospital in London will take part.

You have radiotherapy and take pazopanib tablets. Then you have surgery.

Radiotherapy
You have a radiotherapy planning scan. The scan helps doctors know how much radiation you need and exactly where you need it. You might also have a radiotherapy mould (or shell) made. This is to keep you still during the treatment.

Then you start radiotherapy. You have it every day, Monday to Friday, with a break at weekends. You have 25 treatments (5 weeks).

Pazopanib
Pazopanib comes as tablets that you take every morning, including the weekends.

You start taking pazopanib tablets 1 week before the start of radiotherapy. And you continue taking them until the end of radiotherapy.

You cannot eat for at least 1 hour before the tablets and after you have had the tablets you must wait at least 2 hours before eating.

Surgery
You have surgery between 6 to 8 weeks after finishing radiotherapy and pazopanib. Your doctor can tell you more about this.

Blood samples
You have some extra blood tests as part of this trial. Researchers want to find out what happens to pazopanib and the effects it has in the body.

You have the extra blood samples before the start of pazopanib and then every week during treatment.

Tissue samples
The trial team will ask you to have 2 samples of tissue (biopsies) taken. You have them before the start of treatment and at the start of week 4 of radiotherapy (day 22).

Researchers want to look at the blood vessels (such as veins) that bring oxygen and other substances to the cancer.

MRI scans
You have 3 extra MRI scans as part of this trial. You have them:

before the start of pazopanib
on the same day, but before, you start radiotherapy
on day 22 of radiotherapy

Researchers want to see if the MRI scans can help to tell how well the treatment is working.

Patient diary
The trial team will ask you to keep a diary to record each time you take pazopanib. This helps your doctor see how many doses of treatment you had.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

a physical examination
blood tests
urine test
a heart trace (ECG )
a CT scan
an MRI scan

During treatment you see the trial doctor every week. You have blood tests and a physical examination.

After you finish radiotherapy and pazopanib, you see the trial doctor after 1 and 2 weeks. Then you have surgery.

After surgery you see the trial doctor every week, for 3 weeks. Then:

every 3 months for a year
every 6 months for 4 years

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of pazopanib are: