
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at having enadenotucirev with chemoradiotherapy for people with cancer of the back passage (rectal cancer) that is locally advanced.
Enadenotucirev is a new virus treatment for cancer.
Locally advanced rectal cancer is cancer that has spread into the surrounding tissue.
Cancer Research UK supports this trial.
Chemotherapy with radiotherapy (chemoradiotherapy) is a treatment for people with locally advanced rectal cancer. The chemotherapy helps make the cancer cells more sensitive to the radiotherapy.
Researchers are looking for ways to make chemoradiotherapy work better. They think enadenotucirev (EnAd) might work.
EnAd is a . It kills cancer cells but causes very few problems to the healthy cells. It only grows in cancer cells and passes from one cancer cell to another. When it reaches healthy cells it stops growing. And so doesn’t harm any healthy cells.
You have EnAd as part of your chemoradiotherapy.
The aims of this trial are to find:
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 all of the following apply. You:
Who can’t take part
You cannot join this trial if any of these apply. You:
This is a phase 1 trial. The trial team needs a maximum of 30 people to join.
Everyone has EnAd and chemoradiotherapy. Depending on when you join the trial you have a low dose or a high dose of EnAd.
There are 6 groups in this trial. The team will tell you which group you are in and the dose of EnAd you are having.
Groups 1 and 4
You have 3 doses of EnAd before chemoradiotherapy. This is over 7 days with 48 hours between each dose.
Groups 2 and 5
You have 3 doses of EnAd before and 3 doses after chemoradiotherapy. You have each 3 doses over 7 days with 48 hours between each dose.
Groups 3 and 6
You have EnAd before, during and after chemoradiotherapy.
Before and after chemoradiotherapy you have 3 doses of EnAd over 7 days with 48 hours between each dose.
During chemotherapy you have 2 doses of EnAd in the 1st week. This is 1 dose on Monday and 1 dose on Friday after your radiotherapy.
All groups
Before chemoradiotherapy you have a planning appointment to work out where to give the radiotherapy and how much to give. You have chemoradiotherapy Monday to Friday for 5 weeks.
You have capecitabine as a tablet. You take it twice a day. You don’t take the capecitabine on the days you have EnAd.
You have EnAd as a drip into a vein. After your 1st dose you stay at the hospital for up to 6 hours. This is so the team can check your:
For all other doses you stay at the hospital for up to 3 hours after you have had treatment. For 30 days after treatment you shouldn’t have physical contact, share cups and cutlery with anyone who might be at a high risk of getting a virus infection. This
includes:
You can be in the same room as these people but no closer than 1 metre. You should also use disposable tissues if you have a runny nose and watery eyes. And put these tissues in the household waste.
Samples
You give blood samples several times during the trial.
The team ask for a piece of the cancer tissue from when you were diagnosed.
You have a sigmoidoscopy during the 2nd week of chemoradiotherapy. The specialist doctor or specially trained healthcare professional (endoscopist) takes 3 samples of tissue (biopsies).
When you have surgery, the team will take a piece of the removed cancer.
They use all these samples to find out how well EnAd worked.
You see the doctor to have some tests before taking part. These tests include:
You see the doctor each week during treatment for blood tests and to see how you are.
You have an MRI scan and CT scan 6 weeks after finishing treatment.
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.
EnAd is a new drug and there might be side effects we don’t know about yet. The side effects we do know about include:
We have information about the side effects of chemoradiotherapy.
Your doctor or a member of the trial team will talk to you about the possible side effects of the treatment before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Maria Hawkins
Cancer Research UK
University of Oxford
PsiOxus Therapeutics Ltd
This is Cancer Research UK trial number is CRUK/17/015.
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.