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AuthorisedTherapeutic confirmatory (Phase III)Interventional

BALLAD Belgium - A trial to evaluate the potential benefit of adjuvant chemotherapy for small bowel adenocarcinoma. The Belgian component of the Global Ballad pooled data analysis.

The BALLAD study is investigating whether chemotherapy given after surgery (called 'adjuvant chemotherapy') is helpful for people diagnosed with a rare type of bowel cancer called small bowel adenocarcinoma. This particular part of the study is happening in Belgium and is contributing to a larger international effort. Researchers want to understand if this extra treatment can stop the cancer from returning, or if new cancer develops, and how it affects how long people live overall. They are also looking at any side effects of the treatment and studying the cancer itself in detail. It’s an important study to help doctors decide the best way to treat this condition in the future.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Groupe Belge D'Oncologie Digestive
Enrolment target
30
Start
20 Nov 2024

What is this study about?

The BALLAD study is an important research project looking into a specific type of cancer called small bowel adenocarcinoma. This is a rare cancer that starts in the small intestine. Often, the main treatment for this cancer is surgery to remove the tumour. After surgery, sometimes doctors recommend extra treatments like chemotherapy to try and make sure all cancer cells are gone and to reduce the chance of the cancer coming back. This additional chemotherapy is called 'adjuvant chemotherapy'.

This study specifically wants to find out if giving adjuvant chemotherapy to people with small bowel adenocarcinoma helps them live longer without the cancer returning or developing again. It's like checking if giving an extra boost after the main treatment makes a real difference. The researchers will be carefully tracking how long people stay cancer-free after their treatment.

By gathering information from many patients, the study aims to give doctors clearer guidance on whether adjuvant chemotherapy is a beneficial treatment for this type of cancer. It will also look at how patients feel during treatment, any side effects, and examine the cancer cells themselves to learn more about this disease. This information is crucial for improving treatments and care for people with small bowel adenocarcinoma in the future.

Key takeaways

  • This study is for a specific, rare bowel cancer.
  • It's checking if extra chemo after surgery helps.
  • Researchers will monitor cancer return and overall health.
  • Participation involves strict medical check-ups.
  • It's part of a bigger international research effort.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 or older. Both men and women can take part.

Beyond these basic requirements, doctors involved in the study will have specific medical criteria to check if the study is right for you. This often includes things like your overall health, the specific details of your small bowel adenocarcinoma, and whether you've had certain treatments already. They will make sure the study matches your particular situation.

These detailed checks are important to ensure your safety and that the study results are clear and helpful for others in the future.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with small bowel adenocarcinoma?
  3. Are you able to receive chemotherapy treatments?
  4. Are you willing to attend regular hospital visits and check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve receiving specific chemotherapy medications after your surgery for small bowel adenocarcinoma. These medications might include drugs like Fluorouracil, Elvorine, Eloxatin, or Xeloda, which are commonly used in cancer treatment. You would receive these treatments according to a schedule set by the study doctors.

The study would also involve regular visits to the hospital or clinic. During these visits, you would have check-ups, blood tests, and scans to monitor your health, how you are responding to the treatment, and to look for any signs of the cancer returning. The study team would track your progress over a period of time to see how well the treatment works and any side effects you might experience. The total duration of your participation, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of receiving closely monitored treatment with medications that your doctors believe could be helpful. The findings from this study could also help improve treatment for many others in the future. However, there are potential risks, as chemotherapy can cause side effects like nausea, tiredness, or hair loss, and the specific drugs used may have their own risks. You will be closely monitored, but it's important to understand these possible side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is 'small bowel adenocarcinoma'?

It's a rare type of cancer that starts in your small intestine, which is part of your digestive system.

What does 'adjuvant chemotherapy' mean?

It refers to chemotherapy given after surgery to help reduce the risk of the cancer coming back.

What is the main goal of this study?

The main goal is to see if giving chemotherapy after surgery helps people live longer without their small bowel cancer returning.

Will I get good medical care if I join?

Yes, you will be very closely monitored by a medical team specifically dedicated to the study throughout your participation.

Is this study only happening in Belgium?

No, this is the Belgian part of a larger, global study called BALLAD, gathering information from different countries.

How to find out more

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

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