AuthorisedTherapeutic exploratory (Phase II)Interventional

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

This research study is for women with advanced ovarian cancer. Doctors are testing a new way to give chemotherapy medicines, which is called 'intensive intraperitoneal therapy'. Instead of going into a vein, the medicine is put directly into the tummy area, hoping it can work more effectively on cancer cells there. This is a Phase II study, meaning researchers are looking closely at how safe this new treatment is and if it shows promise in helping patients. They'll be checking for side effects and how well the treatment shrinks the cancer. The study is open to adult women with ovarian cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Regional Du Cancer De Montpellier

Enrolment target

Start

05 Sep 2024

Ovarian Cancer

What is this study about?

This study is about a type of cancer treatment called 'intensive intraperitoneal therapy' for women who have advanced ovarian cancer. Ovarian cancer is a disease where harmful cells grow in the ovaries, which are part of a woman's reproductive system. 'Advanced' means the cancer has spread from where it started.

Usually, chemotherapy medicines are given through a drip into a vein. But in this study, the medicines are put directly into the tummy area (what doctors call 'intraperitoneal'). The idea behind this is that it might allow higher doses of the medicine to reach the cancer cells in the tummy, where ovarian cancer often spreads, while potentially reducing side effects in other parts of the body.

This is a 'Phase II' study. This means it's an important step where doctors are carefully checking to see if this new treatment method is safe for patients and if it has a good effect on the cancer. They are trying to find out the best way to give the treatment and if it helps patients live longer or have better quality of life. It's an exploration to see if this method could be a better option in the future.

Key takeaways

This study evaluates a special way to give chemo for advanced ovarian cancer.
Chemo medicine goes directly into the tummy, not into a vein.
It's a 'Phase II' study, checking safety and effectiveness.
Open to women aged 18 and above with advanced ovarian cancer.
Participation involves regular treatments, tests, and follow-up visits.

Who may be eligible?

This study is looking for women who are 18 years old or older. There is no upper age limit, meaning older women can also take part if they are suitable.

To join, you must have been diagnosed with advanced ovarian cancer. Doctors will need to do some tests to make sure that this specific treatment is right for your type and stage of cancer.

Other specific health checks will be carried out by the study doctors to make sure it's safe for you to take part. For example, they will check your general health, how well your organs are working, and make sure you don't have any other serious health conditions that could make the treatment risky.

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.

Are you a woman?
Are you 18 years old or older?
Have you been diagnosed with advanced ovarian cancer?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the intensive intraperitoneal therapy as outlined by the research team. This would involve regular visits to the hospital for your treatment. The treatment would be given directly into your tummy, likely through a small tube or port that is placed for this purpose. You would also have several medical assessments throughout the study, which could include blood tests, scans (like CT scans), and physical exams to monitor your health and how the treatment is working. The study team would explain the full schedule of treatments and checks. After the main treatment period, you would likely have follow-up appointments to see how you are doing over time. The total duration of your participation would be explained by the study team, covering both treatment and follow-up.

Potential risks and benefits

Taking part in this study means you might receive a new treatment that could potentially work better for your cancer than standard options. However, as with any new treatment, there are potential risks and side effects that doctors are carefully monitoring. These could include discomfort or infection from the treatment being given into your tummy, or other side effects common with chemotherapy, which will be fully explained to you. It's important to remember that you can decide to leave 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.

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Unverified
France

Common questions

What is 'intraperitoneal' therapy?

It means the chemotherapy medicine is put directly into the space inside your tummy, rather than into a vein.

What is ovarian cancer?

It's a type of cancer that starts in the ovaries, which are part of a woman's reproductive system.

What does 'advanced' ovarian cancer mean?

It means the cancer has spread beyond where it first started in the ovary.

Is this a new type of treatment?

Yes, this study is testing a new way of giving chemotherapy for ovarian cancer to see if it's safe and effective.

Who can join this study?

Women aged 18 or over with advanced ovarian cancer, after doctors check if it's suitable for them.