CompletedPhase IIIInterventional

Evaluating the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma

Small bowel cancer is uncommon, and the main treatment is surgery to remove the tumour. After surgery, doctors are not always sure if giving extra chemotherapy helps stop the cancer from coming back. This clinical trial, called the BALLAD study, is comparing different approaches to find the best care. People who join the study will either be monitored closely after their operation or receive chemotherapy. The chemotherapy drugs being tested include capecitabine, 5-FU, and oxaliplatin. These medicines are already widely used for other bowel cancers. By taking part, participants help doctors learn whether chemotherapy after surgery lowers the chance of cancer returning and helps people live longer, healthier lives. The study is open to adults who have recently had surgery to completely remove their small bowel tumour.

At a glance

Status

Completed

Phase

Phase III

Sponsor

Greater Glasgow and Clyde Healthboard and University of Glasgow

Enrolment target

880

Start

25 Aug 2015

Estimated completion

31 Aug 2022

Small bowel adenocarcinoma

What is this study about?

The small bowel is part of your digestive system, sitting between your stomach and your large bowel. Cancer in the small bowel is quite rare. When it is found, the main treatment is an operation to remove the tumour. For many other types of bowel cancer, doctors often recommend chemotherapy after surgery to kill any tiny, invisible cancer cells that might be left behind. However, because small bowel cancer is so rare, there has not been enough clear research to know if extra chemotherapy is truly helpful.

This trial aims to answer that important question. Researchers want to compare what happens when patients receive chemotherapy after their operation versus what happens when they are carefully monitored without chemotherapy. The medicines used in the study include capecitabine, 5-FU, and oxaliplatin. These are standard chemotherapy drugs that doctors already use every day for large bowel cancer.

Finding the right answer matters because chemotherapy can cause side effects. If chemotherapy works well, it could save lives and stop cancer from returning. On the other hand, if it does not provide a clear benefit, future patients can safely be spared unnecessary treatment and its unwanted side effects. The results will help doctors create clearer, better treatment guidelines across the NHS and worldwide.

Key takeaways

The trial tests whether chemotherapy after surgery helps stop small bowel cancer from coming back.
The medicines used are capecitabine, 5-FU, and oxaliplatin, which are standard cancer treatments.
Participants are placed into a treatment group or a close monitoring group by chance.
You must join within 14 weeks of having your tumour removed.
Joining is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for adults aged 16 and over who have recently had surgery to remove small bowel adenocarcinoma (cancer of the small bowel). To be able to join, the surgeon must have successfully removed the whole tumour, with scans showing no signs of cancer left behind. You must be well enough to carry out everyday activities, even if you cannot do heavy work.

Timing is very important for this study. You need to be registered within 14 weeks of your operation and, if you are assigned to have chemotherapy, start treatment within 16 weeks of your surgery date.

You will also need routine blood tests to check that your kidneys, liver, and bone marrow are working well enough to handle chemotherapy safely. People who still have signs of cancer on their scans, or whose blood test results fall outside safe limits, will not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with small bowel adenocarcinoma.
I have had surgery that completely removed the tumour.
My operation took place less than 14 weeks ago.
My recent scans show no remaining cancer.
I am aged 16 or over and feel well enough to manage daily tasks.

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will place you into one of the study groups by chance (a process called randomisation). One group will have regular check-ups and monitoring without chemotherapy. The other groups will receive chemotherapy, either with a single drug (like capecitabine or 5-FU) or a combination of drugs including oxaliplatin.

Chemotherapy can be given as tablets to swallow at home, through a drip into a vein at the hospital, or a mixture of both. Treatment usually lasts for about six months. During this time, you will visit the hospital clinic regularly for blood tests, health checks, and to discuss any side effects with your care team.

After your treatment ends—or if you are in the monitoring group—you will attend follow-up clinic visits and have scheduled scans over several years. This allows your doctors to keep a close eye on your health and check whether the cancer remains clear.

Potential risks and benefits

Taking part in this study may or may not benefit you directly. If you receive chemotherapy, it might lower the chance of the cancer returning, but this cannot be guaranteed. Your participation will also help doctors find the best treatments for people diagnosed with this rare cancer in the future. Chemotherapy can cause side effects, such as tiredness, feeling sick, diarrhoea, an increased risk of infections, or tingling in the hands and feet. Your hospital team will monitor you closely and provide medicines to help manage any problems. Taking part is completely voluntary, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Beatson West of Scotland Cancer Centre
City only
Glasgow, Scotland

Common questions

What is small bowel adenocarcinoma?

It is a type of cancer that starts in the lining of the small bowel, the part of the digestive tract that absorbs nutrients from your food.

Can I choose whether I receive chemotherapy or just monitoring?

No. A computer programme assigns you to a group by chance. This helps make sure the study results are fair and reliable.

How is the chemotherapy given?

Depending on the group you are in, it may be given as tablets taken by mouth, as an infusion into a vein at the hospital, or a combination of both.

Will taking part cost me anything?

No. The trial treatments and tests are provided through the NHS, though you may need to travel to the hospital for visits.

What happens if I change my mind later?

You can leave the study at any point. Your normal cancer care and relationship with your doctors will not be affected in any way.

How to find out more

Sarah Bradley

sarah.bradley@glasgow.ac.uk 0141 301 7540 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.