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AuthorisedPhase II and Phase III (Integrated)Interventional

Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for resectable colorectal peritoneal metastases: a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6).

This important study, called CAIRO6, is looking at the best way to treat bowel cancer that has spread to the lining of the tummy (peritoneum) and can be operated on. Some people with this type of cancer have chemotherapy before their surgery, which involves removing the visible cancer and then a special heated chemotherapy wash directly inside the tummy, called HIPEC. Other people have the surgery and HIPEC straight away. This study wants to find out if having chemotherapy before surgery helps people live longer than having surgery and HIPEC alone. It’s comparing both approaches to see which one works better, using common chemotherapy medicines. This will help doctors decide the best treatment for patients in the future.

At a glance

Status
Authorised
Phase
Phase II and Phase III (Integrated)
Sponsor
Catharina Ziekenhuis Stichting
Enrolment target
358
Start
12 Nov 2024

What is this study about?

When bowel cancer spreads, it can sometimes affect the lining of the tummy, which is called the peritoneum. If this spread can be seen and removed by surgery, there are different ways doctors might try to treat it. One approach is to have surgery to remove the cancer, followed by a special treatment called HIPEC. HIPEC involves warming chemotherapy drugs and washing them around inside the tummy for a short time after the cancer has been removed, to try and kill any tiny cancer cells left behind.

Another approach is to have a course of chemotherapy drugs through your vein or by tablets, before having the surgery and HIPEC. The idea behind this is that the chemotherapy first will shrink the cancer or kill some cells, making the surgery more effective. This study, called CAIRO6, is designed to compare these two main ways of treating this type of cancer.

The main goal of CAIRO6 is to see if people who have chemotherapy before their surgery and HIPEC live longer than those who just have surgery and HIPEC. By carefully comparing these two treatment plans, the researchers hope to find out which one is more effective. This information will be vital in helping doctors in the UK and worldwide make the best decisions for patients with bowel cancer that has spread to the tummy lining in the future.

Key takeaways

  • This study compares chemotherapy before surgery versus surgery alone for bowel cancer spread.
  • It focuses on cancer spread to the tummy lining that can be removed surgically.
  • The main goal is to see which treatment helps people live longer.
  • Standard chemotherapy drugs are used, not brand new ones.
  • Participation involves random assignment to a treatment group and long-term follow-up.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. The study is open to both men and women. Importantly, you must have bowel cancer that has spread to the lining of your tummy (peritoneum), and doctors must believe that this spread can be removed completely by surgery.

There will be other detailed medical checks to make sure the treatment is safe for you and that the study results will be reliable. For instance, doctors will check your overall health, other medical conditions you might have, and results from blood tests and scans.

It's important to discuss your full medical history with your doctor if you are interested in this study. They will be able to tell you if you meet all the specific requirements to join.

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. Do you have bowel cancer that has spread to the lining of your tummy?
  3. Have your doctors said that this cancer spread can be removed by surgery?
  4. Are you willing to be randomly assigned to one of the two treatment plans?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of two treatment groups, like flipping a coin, so it's fair. One group will receive chemotherapy before surgery and HIPEC, and the other group will have surgery and HIPEC straight away.

The chemotherapy drugs may be given through a drip (infusion) into a vein, or as tablets you take by mouth. The length and number of chemotherapy cycles will vary depending on the specific drugs given. After this, or if you're in the other group, you will have surgery to remove the cancer and then the HIPEC treatment.

After your treatment, you will have regular check-ups with your study doctor for many years. These check-ups will involve things like physical exams, blood tests, and scans (like CT or MRI scans) to monitor your health and see how well the treatment worked over time. The study will follow people from the time they are diagnosed with spread to the lining of the tummy until their death or until the study stops gathering information, whichever comes first.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from closer monitoring of your health or receive a treatment that could be more effective. However, the exact benefits are not guaranteed, as the study is designed to find out which treatment is better. Potential risks are mainly related to the side effects of the chemotherapy drugs (like feeling sick, tiredness, hair loss, or infections) and the surgery itself (like pain, infection, or problems healing). The study doctors and nurses will closely monitor you for any side effects and provide care to manage them. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Common questions

What does 'resectable' mean?

It means the doctors believe the cancer and its spread can be completely removed by surgery.

What is HIPEC?

HIPEC stands for Hyperthermic Intraperitoneal Chemotherapy. It's a treatment where warm chemotherapy liquid is washed around inside the tummy after surgery to kill tiny cancer cells.

Will I get to choose my treatment group?

No, you will be randomly assigned to one of the two groups, like drawing lots, to ensure the study is fair and unbiased.

Are the chemotherapy drugs new or experimental?

No, the chemotherapy drugs used in this study are standard treatments already approved and used for bowel cancer.

How long will I be followed in the study?

You will be followed from your diagnosis until your death or the study officially ends its data collection, which could be many years.

How to find out more

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

Discussion

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