A trial looking at enadenotucirev with chemoradiotherapy for rectal cancer (CEDAR)

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

Cancer type:

Bowel (colorectal) cancer

Rectal cancer

Status:

Closed

Phase:

Phase 1

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.

More about 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 virus Open a glossary item . 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 best dose of EnAd to give
when to give it
how often to give it
how well it works with chemoradiotherapy

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 all of the following apply. You:

have rectal cancer that is an adenocarcinoma and has spread into the surrounding tissue (invasive) or you have bowel cancer that has spread into the surrounding tissue (locally advanced)
have cancer that can’t be removed by surgery
are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
have satisfactory blood test results
are willing to use reliable contraception during the trial and for 6 months after if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

have had chemotherapy within 28 days of starting treatment
still have ongoing side effects of previous chemotherapy unless the side effects are mild
have a disease that affects how well your immune system works
take medication such as steroids that damps down your immune system
have had your spleen removed
have had a bone marrow transplant
have had an organ transplant
have an autoimmune disease that needs treatment that affects the whole body (systemic treatment ) apart from vitiligo, type 1 diabetes, a thyroid gland that isn’t making enough hormones (hypothyroidism) needing hormone replacement only, psoriasis
have lung problems such as damaged or scarred lung tissue, inflammation of the lungs or active pneumonia
have HIV, hepatitis B, hepatitis C or any other active virus infection
have an infection that needs antibiotics
have repeated high temperatures (38C degrees or more) and an active infection
have had radiotherapy to the area between your hips (pelvis)
have another cancer apart from carcinoma in situ of the cervix successfully treated by cone biopsy and successfully treated non melanoma skin cancer
have angina that isn’t controlled by medication
have had a heart attack in the past 6 months
have bowel problems such as not been able to control your bowels, Crohn’s disease or you are taking more than 6 tablets such as loperamide (Imodium) that helps control diarrhoea
have a risk of your bowels being blocked due to the cancer apart from a colostomy that isn’t working
are taking medication that fights viruses within 7 days of starting treatment
are having interferon that is pegylated within 14 days of starting treatment
have taken part in another clinical trial within 28 days of agreeing to take part in this one
have had a blood clot in the deep veins (DVT) or a blood clot in the lungs (pulmonary embolism) in the past year
have been in hospital due to a major bleeding problem within the past year
are taking medication such as warfarin that thins your blood
have a low level of the DPD enzyme
have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part
are pregnant or breastfeeding

Trial design

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:

pulse
blood pressure
breathing
temperature

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:

women who are pregnant or breastfeeding
children under 1 year old
anyone who has a disease such as HIV that affects how well their immune system works or someone who is taking medication such as steroids that damp down their immune system

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.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

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

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.

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.

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:

high temperature, chills and shivers in the first 24 hours after
flu like symptoms for a few days especially after the 1st dose
an allergic reaction at the injection site – the skin might become red, inflamed and or itchy
a more serious allergic reaction where your blood pressure can drop and you feel unwell
headache
feeling or being sick
diarrhoea
not enough fluid in the body (dehydration) with low blood pressure and a fast heartbeat
shortness of breath or difficulty breathing
inflammation of the liver
a drop in the number of white blood cells causing an increased risk of infection
a drop in the number of blood cells called platelets causing an increased risk of bruising and bleeding
swelling where your cancer is
infection or inflammation of the bladder – symptoms include passing urine more often, pain when passing urine or blood in your urine
protein in your urine
a very small risk of a blood clot in a vein (DVT) or blood clot in the lungs (pulmonary embolism)