"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 radiotherapy and olaparib for cancer of the food pipe (ROCOCO)
This trial is looking at a drug called olaparib alongside radiotherapy for cancer of the food pipe (oesophageal cancer). The trial is supported by Cancer Research UK
If you can’t have surgery to remove oesophageal cancer you may have radiotherapy and chemotherapy. But you must be in quite good health to have this type of treatment and some people are not well enough to have the chemotherapy drugs. They may have radiotherapy alone which can shrink the cancer and improve symptoms for a period of time, but it does not cure oesophageal cancer.
The people taking part in this trial can’t have chemotherapy with radiotherapy. Some will have radiotherapy alone. Some will have a drug called olaparib alongside radiotherapy.
Olaparib is a type of biological therapy called a PARP inhibitor. It blocks an
In this trial, some people will have radiotherapy and olaparib, some will have radiotherapy alone. The main aim of the trial is to find the highest dose of olaparib you can have safely alongside radiotherapy for oesophageal cancer.
Who can enter
You may be able to enter this trial if you
- Have oesophageal cancer that is either adenocarcinoma or squamous cell carcinoma
- Are able to have radiotherapy, but cannot have radiotherapy and chemotherapy together
- Have a tumour that is less than 10cm in length
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant
As well as the above, you will only be able to have olaparib if you
- Have satisfactory results from blood tests and tests to see how well your lungs are working
- Are able to swallow tablets
You cannot enter this trial if you
- Have cancer that has spread to another part of your body (apart from nearby
lymph nodesthat can be treated with radiotherapy)
- Have already had chemotherapy or radiotherapy for oesophageal cancer
- Have had another experimental drug in the last 2 weeks
- Have already had olaparib or another drug of the same type
- Have had major surgery in the last 2 weeks or haven’t recovered from earlier surgery
- Have a tube called a stent in place to keep your food pipe open
- Have had any other cancer unless it was a very early stage and was successfully treated at least 5 years ago
- Have a condition called myelodysplastic syndrome or acute myeloid leukaemia
- Have had a heart attack in the last 3 months or have any other serious medical condition that the trial team think could affect you taking part
- Have problems with your liver such as hepatitis
- Have fits (seizures) that can’t be controlled with medication
- Are known to be HIV positive
- Are pregnant or breastfeeding
And you can’t have olaparib in the trial if you
- Take other medication that affects a body protein called CYP3A4
- Have had pneumonia in the last 3 months or have had certain other heart or lung problems – the trial team can advise you about this
- Have problems with your
digestive systemthat could affect how you absorb tablets
- Are known to be very sensitive to olaparib or anything in it
This phase 1 trial will recruit 36 people.
- 24 people will have olaparib and radiotherapy
- 12 people will have radiotherapy alone
Whether or not you have olaparib will depend on a number of factors, including exactly when you join the trial.
The first few patients joining the trial will have a low dose of olaparib. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
There is a 1 month gap between each of these groups of patients. This is for the trial team to check for any unexpected side effects that may take longer to develop. If you join the trial during one of the gaps, you won’t have olaparib, you’ll have radiotherapy alone. And some people won’t have olaparib because they don’t want to have it, or the trial team don’t think they are well enough to have it.
If you don’t have olaparib, you may have a slightly higher dose of radiotherapy. Your doctor will work out the best treatment plan for you, but is likely to take either 4 weeks or just over 6 weeks.
If you have olaparib, you take tablets twice a day. You have radiotherapy for 5 weeks. You start taking the tablets 3 days before starting radiotherapy and take them every day until you finish radiotherapy.
The trial team will ask everybody taking part to give some blood and tissue samples before, during and after treatment. They will use these to look for substances called
You see the trial team before you start treatment and have some blood tests. If you haven’t already had them, you also have the following tests
If you are going to have olaparib, you also have a test called an endoscopic ultrasound and tests to see how well your lungs are working (lung function tests).
You have 2 hospital visits for radiotherapy planning. People having olaparib have 1 extra hospital visit after their radiotherapy planning.
Everybody goes to hospital every day (Monday to Friday) to have radiotherapy. You have a physical examination and blood tests once a week. In the 4th week, the trial team will take 2 samples of tissue from your skin (
When you finish radiotherapy, you see the trial team and have a physical examination and blood tests once a week for another 4 weeks .
There is another hospital visit 3 months after finishing treatment. Everybody has a physical examination and blood tests. People who have taken olaparib also have a CT scan, an endoscopy and lung function tests.
Everybody then sees the trial team after 6 months, 9 months, 1 year, 18 months, 2 years and 3 years.
The most common side effects of radiotherapy for oesophageal cancer are tiredness and difficulty swallowing.
As olaparib is still quite a new drug, there may be side effects we don’t know about yet. Possible side effects include
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.
Dr Andrew Jackson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Christie NHS Foundation Trust
This is Cancer Research UK trial number CRUKD/11/012.