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.
A trial of chemotherapy and bevacizumab before surgery for rectal cancer (BACCHUS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at different combinations of chemotherapy drugs with bevacizumab before surgery for rectal cancer. The trial is supported by Cancer Research UK.
Cancer that starts in the back passage (
Radiotherapy helps to stop the cancer from coming back in the area where it started. Chemoradiation can also help to stop cancer spreading to other parts of the body. But because of the side effects, doctors can’t give as much chemotherapy alongside radiotherapy as they could give if you have chemotherapy on its own. Researchers think that having more drug treatment instead of radiotherapy may be better at stopping the cancer coming back in other parts of the body.
The aim of the trial is to see how good these drug combinations are at shrinking rectal cancer and stopping it from coming back after surgery.
Who can enter
You may be able to enter this trial if
- You have been diagnosed with cancer of the back passage (rectal cancer) that your specialist thinks can be removed with surgery
- An MRI scan shows that your cancer has grown into (or through) the outer lining of the rectal wall or into surrounding body tissues and may have spread to
lymph nodes, but has not spread to other body organs
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are between 18 and 75 years old
- You are willing to use reliable contraception during the trial and for at least 6 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have had radiotherapy to the area between your hip bones (your
- Are currently taking drugs called bisphosphonates
- Have had another experimental drug in the last month
- Have had any other cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated
- Have had a heart attack or stroke in the last 2 years, or have a condition affecting the veins in your legs (peripheral vascular disease)
- Have problems with bleeding or your blood not clotting
- Take medication to thin your blood (anticoagulants) – you may be able to take part if you are taking a low dose to control another medical condition (your doctor can advise you about this)
- Have certain heart or lung problems (the trial team can advise you about this)
- Take a high dose of aspirin or have taken a drug called clopidrogel (for blood clotting problems) in the last 10 days
- Need to take regular medication to control diarrhoea
- Have another serious medical condition that is not well controlled with medication
- Have an infection and have had antibiotics in the last week
- Are known to be very sensitive to any of the drugs in the trial
- Have not been able to have drugs similar to the chemotherapy drug fluorouracil in the past because of bad side effects
- Have a serious wound, an ulcer or a broken bone that won’t heal
- Have a tube called a stent in your bowel or back passage
- Have problems with your
digestive systemthat could affect how you absorb drugs
- Are known to have HIV, hepatitis B or hepatitis C
- Have any other medical condition or mental health problem that the trial team think could affect you taking part
- Are a current smoker, or have had problems with drugs or alcohol that the trial team are concerned about
This phase 2 trial will recruit about 60 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part has bevacizumab every 2 weeks.
- People in group A also have drugs called fluorouracil (5FU),
folinic acidand oxaliplatin (FOLFOX)
- People in group B have 5FU,folinic acid, oxaliplatin and irinotecan (FOLFOXIRI)
Each 2 week period is called a cycle of treatment. You have up to 6 cycles of treatment, lasting 12 weeks all together. But if you have bad side effects or if it is not helping to shrink your cancer, you will stop the treatment sooner. You don’t have bevacizumab in the last cycle of treatment.
You have all the drugs through a drip into a vein. You may have a central line put into a vein in your chest. If so, this will stay in place throughout your treatment.
You spend a few hours in hospital each time you have the drugs, but you have 5FU over 48 hours. You have it via a small pump which you can go home with. When the 5FU has finished you will need to go back to hospital to have the pump disconnected. It may be possible for the practice nurse at your GP surgery to do this, so you won’t need to go back to the hospital.
When you finish the trial treatment, your doctors will look at results of scans to decide if you can go on to have surgery. If you do have surgery, this takes place about 6 weeks after your last cycle of treatment.
If you don’t have surgery, you will leave the trial. Your doctor will talk to you about other treatment options.
You see the trial team and have some tests before you start treatment. The tests include
You go to hospital for treatment every 2 weeks. Before each cycle of treatment, you have a physical examination, blood tests and urine tests.
You have another PET scan and MRI scan before your 4th cycle of treatment.
After your last cycle of treatment, you have more blood tests, urine tests, an ECG, a CT scan, and an MRI scan.
You see the trial team and have a physical examination and blood tests every 2 weeks until you have surgery.
After surgery, a member of the trial team will examine you 2 days later, 1 month later and again 3 months later. You will have another CT scan after about 3 months.
The trial team will continue to monitor your progress for up to 3 years after your surgery. But you should not have to make any more trips to hospital than would usually be expected after this type of surgery.
The side effects of the chemotherapy drugs in this trial include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Tiredness (fatigue)
- Numbness or tingling in your hands or feet (peripheral neuropathy)
- Feeling or being sick
- Pain in the vein where you have the drugs
- Soreness, redness and peeling on the palms of the hands and soles of the feet (palmar-plantar syndrome)
- Sore mouth
With irinotecan, there are some side effects that you may have straight away, while you are having the treatment, these include
- Increased sweating
- Increased saliva production
- Watery eyes
- Abdominal cramps
- Diarrhoea which can occasionally be severe – it can happen on the day you are having treatment but may also happen a day or so later
The side effects of bevacizumab include
- High blood pressure
- Feeling sick
- Pain in your joints, muscles, chest and tummy (
- Slow wound healing
- Protein in your urine
- An increased risk of bleeding
- Loss of appetite
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 Rob Glynne-Jones
Cancer Research UK
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUK/10/003.