A trial looking at chemotherapy with other treatments for bowel cancer that has spread (ORCHESTRA)

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer
Secondary cancers

Status:

Open

Phase:

Phase 3

This trial is looking at adding other treatments to chemotherapy for bowel cancer that has spread elsewhere in the body. Bowel cancer that has spread is called metastatic or advanced bowel cancer. 

The trial is for people who:

  • are due to have chemotherapy
  • have cancer spread to at least 2 different organs in the body
  • can’t have treatment with the aim to cure it

More about this trial

Chemotherapy is the usual treatment for advanced bowel cancer. Doctors are looking for ways to improve treatment. 

They think having other treatments to get rid of as much cancer as possible might help. This is debulking treatment. These treatments might include:

These debulking treatments are not new. They are usual treatments for cancer that has spread to a few places in the body. But it is not usual to have them for cancer that is more widespread. 

In this trial everyone has chemotherapy to start. Then some people have chemotherapy on its own. And some have chemotherapy and a debulking treatment. 

The main aims of the trial are to:

  • find out if adding debulking treatment to chemotherapy increases the length of time people live
  • learn more about the side effects
  • find out more about 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. 

Who can take part

You may be able to join this trial if you have bowel cancer spread to 2 or more different organs in the body. And at least 1 of the following also apply:

  • more than 1 area of cancer spread is outside the liver OR
  • more than 5 areas of cancer spread in the liver are not in the same part (lobe) of the liver OR
  • you have cancer spread in the lymph nodes Open a glossary item in the chest or tummy (abdomen), the adrenal glands Open a glossary item, tissue between the lung and the lining of the chest cavity or the lining of the tummy (peritoneum)  

As well as the above the following must also apply:

  • you are due to have chemotherapy but it is not with the aim to cure it
  • it is possible to remove as much cancer as possible with debulking treatment
  • you are well enough to carry out all your normal activities but you might not be able to do heavy physical work (performance status of 0 or 1)
  • you have satisfactory blood test results
  • you are willing to use contraception during treatment if you or your partner could become pregnant
  • you are at least 18 years old 

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related 
You:

  • have cancer that has spread only to the liver 
  • have cancer that has spread to the brain
  • are suitable to have heated chemotherapy directly into the abdomen after surgery (HIPEC)
  • had standard first line chemotherapy for less than 6 months before the cancer spread to different parts of the body. You might be able to join if you had capecitabine for less than 6 months with radiotherapy for cancer of the back passage (rectum) before you had surgery.
  • are having or have had treatment for bowel cancer including chemotherapy, immunotherapy or an experimental drug within 4 weeks of starting treatment in this trial
  • have had any other cancer in the past apart from squamous cell skin cancer Open a glossary item, basal cell skin cancer Open a glossary item or any other carcinoma in situ (CIS Open a glossary item) that was successfully treated or for any other cancer and there has been no signs of the cancer for 5 years 

Medical conditions
You:

  • have heart problems such as a heart attack in the last 6 months, an abnormal heart rhythm that isn’t controlled with medication or high blood pressure that isn’t controlled with medication
  • have a moderate to severe infection that is not getting better with treatment
  • take ongoing treatments including a steroid drug called dexamethasone, medication to stop fitting or drugs to help control an abnormal heart rhythm apart from digoxin or beta blockers
  • have a severe allergy that can’t be controlled with a premedication to the contrast medium Open a glossary item that is used when you have a CT scan
  • have any other medical condition, mental health problem or problem with drugs or alcohol that the trial team think will affect you taking part in the trial 

Other 
You:

  • are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It is taking place in the UK and the Netherlands. The team hope to find 478 people to join including 70 from the UK. 

Initial chemotherapy
Everyone has standard chemotherapy Open a glossary item first. This includes 1 of the following combinations of treatment: 

  • capecitabine and oxaliplatin (XELOX)
  • 5-FU, oxaliplatin and folinic acid (FOLFOX)

You have treatment in cycles Open a glossary item. You have 3 cycles of XELOX or 4 cycles of FOLFOX. 

You then have a scan to check if treatment has worked. If your cancer has stayed the same or got smaller you are put into a treatment group at random by a computer. There are 2 treatment groups. Neither you nor your doctor can decide which group you are in. You have 1 of the following: 

  • continue with chemotherapy (group A)
  • debulking treatment and then continue with chemotherapy (group B)

You won’t be able to continue with the trial if your cancer gets worse. Your doctor will discuss other treatments with you. 

More chemotherapy (Group A)
You continue with XELOX or FOLFOX chemotherapy. You have this for as long as the treatment is working and the side effects aren’t too bad. 

Debulking treatment and then continue with chemotherapy (Group B)
For people whose cancer got smaller after initial chemotherapy you have 1 cycle of chemotherapy followed by debulking treatment.

People whose cancer stayed the same after initial chemotherapy have:

  • 3 or 4 more cycles of XELOX or FOLFOX
  • a scan

If your cancer stays the same or gets smaller you 1 have more cycle of chemotherapy followed by debulking treatment. But you can’t go on to have debulking treatment if your cancer gets worse. 

The possible debulking treatments include:

  • surgery to remove as much cancer as possible
  • a type of radiotherapy called stereotactic radiotherapy
  • having chemotherapy directly into the tumour in the liver (chemoembolisation Open a glossary item or TACE)
  • treatment using heat to destroy cancer (ablation treatment)

A team of medical specialists decide which debulking treatment you should have. Where possible you have surgery first. Then the debulking treatment to the other areas of cancer spread if possible. 

To have TACE your doctor puts a fine tube (catheter) into your groin. You then have a chemotherapy drug through the catheter directly into the area of cancer. The drug is inside tiny spheres. These then block the blood flow to the cancer. 

To have ablation treatment you have an anaesthetic Open a glossary item. You then have a CT scan Open a glossary item or an ultrasound scan Open a glossary item. Your surgeon or radiologist use the scan to guide a needle through your skin into the tumour. The needle heats up and kills the cancer cells. Some people might have ablation treatment when they have surgery. 

You might need to have a PET-CT scan Open a glossary item before you start radiotherapy treatment. This is to plan the treatment. The number of radiotherapy sessions you have depends on your treatment plan. The trial doctors can tell you more about this.

Quality of life
You fill in questionnaires before starting treatment, at set times during and after treatment. The questions ask about how you are feeling and about any side effects you have. This is a quality of life study.

Hospital visits

You see a doctor and have some tests before you join the trial. These include:

  • physical examination
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • CT scan or PET-CT scan 

You go to hospital for all your treatment. 

The trial team can tell you more about your surgery and how long you stay in hospital for afterwards.

You stay in hospital for a few days if you have TACE or ablation treatment. 

When you finish treatment you see the trial team:

  • at 1 month
  • every 3 months for the first 2 years
  • every 6 months after the first 2 years

You have these check ups until your cancer gets worse. 

You have a CT or PET-CT scan:

  • after initial chemotherapy
  • every 3 months after that for the first 2 years
  • every 6 months after that for 2 years

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

The most common side effects of TACE include:

  • a raised temperature (fever)
  • feeling or being sick
  • pain in your tummy (abdominal pain) 

The most common side effects of ablation include:

  • fever
  • muscle ache
  • feeling or being sick 

These usually gets better within 10 days. 

The most common side effects of radiotherapy are:

The possible risks of having surgery include:

  • pain
  • bleeding 
  • infection

We have more information about:

Location

London
Southampton

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

Dr Lotte Bakkerus

Supported by

Radboud University Medical Center

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16928

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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