A study looking at cediranib (AZD2171) and AZD6244 with chemotherapy and radiotherapy for rectal cancer (DREAM)

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




Phase 1

This study is looking at adding new drugs to the standard treatment for cancer that starts in the back passage (rectum) and has grown into surrounding body tissue. This trial is supported by Cancer Research UK.

Doctors often treat cancer of the rectum Open a glossary item with radiotherapy and chemotherapy (chemoradiotherapy), followed by surgery. One of the chemotherapy drugs you can have is called capecitabine. But researchers are looking for ways to improve treatment.

This trial is made up of 2 studies (‘dual studies’) testing 2 drugs called cediranib (also known as AZD2171) and AZD6244. They are both types of biological therapy. Some of the people taking part will have 1 drug, some will have the other.

Cells normally divide in an organised way. But in cancer cells, proteins that help to control cell growth can change and make the cells grow more quickly. Some of these proteins are called mitogen activated protein kinases (MEK). AZD6244 reduces the amount of MEK (it is a MEK inhibitor Open a glossary item), and may slow down or stop the growth of cancer.

The way cancer grows is also affected by growth factors that help cancer cells to develop a blood supply (angiogenesis). One of the growth factors involved is called vascular endothelial growth factor (VEGF). Cediranib reduces the amount of VEGF. It is an ‘anti angiogenic drug’ and may slow down the growth of cancer.

The aims of this trial are to

  • Find the highest dose of each drug that people can have safely at the same time as chemoradiotherapy for rectal cancer
  • See what happens to the growth of the cancer during treatment

Who can enter

You can enter this trial if

  • You have been diagnosed with rectal cancer that has grown into (or very near to) the membrane covering the outside of the bowel, or is stage T3 and less than 5cm from your anus
  • Your doctors don’t think it would be possible to remove all the cancer and a border of healthy tissue around it (clear margins Open a glossary item) with surgery as your first treatment
  • Your doctors do think it will be possible to treat your cancer with radiotherapy
  • You have satisfactory blood test results
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if you

  • Have cancer that has spread somewhere else in the body (metastatic cancer Open a glossary item)
  • Have already had chemotherapy or radiotherapy for rectal cancer
  • Have had major surgery to your chest or tummy (abdomen Open a glossary item) in the last 2 weeks, or any other surgery if the wound has not completely healed
  • Are not able to have surgery
  • Have another condition that means you may not be able to have radiotherapy such as ulcerative colitis, Crohn’s disease or a fistula Open a glossary item
  • Have a blockage in the bowel (bowel obstruction) or an infection in the pelvis
  • Have a condition called DPD deficiency (which means you cannot have certain types of chemotherapy)
  • Have high blood pressure that cannot be controlled with medication, or a heart problem that is a cause for concern
  • Have an infection that cannot be controlled, or any other medical condition that could affect you taking part in the study
  • Cannot absorb tablets for any reason, including sickness that cannot be controlled with medication and inflammatory bowel disease
  • Have or have had any other type of cancer
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Are pregnant or breastfeeding


  • If you are known to be sensitive to cediranib, or have had recent bleeding problems or blood clots, you cannot take part in the cediranib study
  • If you have already had a MEK inhibitor, you cannot take part in the study of AZD6244

Trial design

The trial will recruit up to 56 people all together. Some people will be involved in the study of cediranib, some will be involved in the study of AZD6244. This will depend on when you join the trial.

Everybody taking part will have

  • Radiotherapy for 5 weeks
  • Capecitabine tablets everyday for 5 weeks during the radiotherapy

Both the trial drugs are tablets that you swallow each day. Whichever drug you have, you start taking it 10 days before your radiotherapy starts, and take it every day until the last day of radiotherapy.

The first few patients taking part in each study will have a low dose of either cediranib or AZD6244. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose of each drug to give. This is called a ‘dose escalation study’.

You have a CT scan or MRI scan 8 weeks after finishing chemoradiotherapy. If this shows that your cancer can be removed, you will have surgery between 2 and 4 weeks later.

The doctors will take some extra blood samples during the trial. And they will get a sample of the tissue that was removed when you had a biopsy to diagnose your cancer. After taking your study drug for about a week, you have a test called a flexible sigmoidoscopy. The doctor puts a thin tube into your back passage and takes another sample of cancer tissue.

The researchers will use these samples to look for substances they can measure that help them tell more about a disease or how a treatment is working – these are called biomarkers. They hope that in the future, biomarkers may help them to work out who is most likely to benefit from the trial drugs.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood and urine tests
  • Heart trace (ECG Open a glossary item)
  • CT scan
  • MRI scan

People taking part in the AZD6244 study will also have

  • Eye tests
  • Heart ultrasound (echocardiogram Open a glossary item)

You go to hospital

  • The day you start taking your study drug
  • Once or twice in the next 10 days
  • Every day (from Monday to Friday) during 5 weeks of radiotherapy
  • 2, 4 and 8 weeks after finishing chemoradiotherapy

The trial team will ask some people taking part to have some extra scans before, during and after treatment. This is to see how the growth of the cancer changes during treatment. If you are in the cediranib study, these will be ‘Dynamic Contrast Enhanced’ MRI scans (DCE-MRI). If you are in the AZD6244 study, you may be asked to have DCE-MRI scans and PET scans.

A member of the trial team will contact you by phone to check how you are 4 months after finishing your chemoradiotherapy. You have follow up appointments every 6 months for 2 years and then one more a year later.

Side effects

As AZD6244 and cediranib are quite new drugs, there may be some side effects we don’t know about. The possible side effects that are known include

Other possible side effects of AZD6244 include

  • Skin rash
  • Swelling of the face or other parts of the body (extremities)
  • Shortness of breath
  • Blurred vision

Other possible side effects of cediranib include

  • Redness or soreness on the palms of your hands or soles of your feet (hand and foot syndrome)
  • Muscle weakness
  • Headache
  • Dry or sore mouth
  • Hoarseness
  • Protein in the urine
  • Bleeding
  • Changes to the way your thyroid gland works
  • Heart changes

There is more information about the side effects of rectal radiotherapy and capecitabine on CancerHelp UK.

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 Mark Saunders

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
The Christie NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUKD/10/013.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 6816

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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