AuthorisedTherapeutic use (Phase IV)Interventional

A multi-centre, four-arm, randomised, double-blind study assessing the dose equivalence of bevacizumab in first-line therapy for ovarian cancer

This study is looking into treatments for women diagnosed with ovarian, fallopian tube, or peritoneal cancer. We are comparing different ways of using a drug called bevacizumab, along with other established cancer medicines like olaparib, carboplatin, and paclitaxel. The main aim is to understand how effective these combinations are at shrinking tumours and how long patients stay well before their cancer progresses. We'll also be tracking any side effects and looking at how the treatments might affect a patient's quality of life. This is a large study (Phase IV), meaning the treatments are already in regular use, but we're trying to find the best way to combine them.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Uniwersytet Medyczny W Lublinie

Enrolment target

332

Start

15 Jul 2024

Patients with ovarian cancer fallopian tube cancer peritoneal carcinoma

What is this study about?

This study is designed for women who have been diagnosed with ovarian cancer, fallopian tube cancer, or cancer originating in the lining of the abdomen (peritoneal carcinoma). These conditions are often treated with a combination of different drugs.

In this research, we are focusing on a particular drug called bevacizumab. It's already an approved treatment, but we want to see if using different doses of it, alongside other standard chemotherapy drugs like olaparib, carboplatin, and paclitaxel, can make a difference. The study will compare different treatment plans to find out which ones work best to shrink tumours and help patients live longer without their cancer progressing.

We will be carefully monitoring how well the tumours respond to treatment, how long patients remain free from their cancer worsening, and any side effects that might occur. We'll also be asking about patients' quality of life to understand how the treatments affect their day-to-day well-being. This type of study (Phase IV) helps us learn more about the best ways to use existing medicines in real patient care.

Key takeaways

This study is for women with ovarian, fallopian tube, or peritoneal cancer.
It tests different ways of using an approved drug called bevacizumab with other cancer medicines.
The aim is to find out which treatments work best to reduce tumour size and keep cancer from getting worse.
Participants will be randomly assigned to one of four treatment groups, and neither they nor their doctors will know which one.
The study also monitors side effects and assesses patients' quality of life.
This is a Phase IV study, meaning it looks at how approved drugs can be used best.

Who may be eligible?

This study is looking for women who are at least 18 years old and have been diagnosed with ovarian cancer, fallopian tube cancer, or peritoneal cancer.

To be considered for the study, you would need to meet certain health criteria that the study doctors will check. This ensures that the treatment is suitable and safe for you, and that the study results are clear.

If you have a diagnosis of one of these cancers and are interested in participating, your doctor will be able to tell you if you meet all the necessary requirements.

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 ovarian, fallopian tube, or peritoneal cancer?
Are you able to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of four different treatment groups. This means neither you nor your doctor will choose which specific combination of medicines you receive; it's decided by chance, like flipping a coin. You will receive standard cancer treatments, including bevacizumab, and potentially olaparib, carboplatin, and paclitaxel, according to the group you are in. Throughout the treatment period, you will have regular hospital visits for medical checks, blood tests, and scans (like CT or MRI) to see how your cancer is responding. We will also ask you to fill out questionnaires about how you are feeling and your quality of life. After your main treatment finishes, there will be follow-up appointments to monitor your health over time. The total length of your participation will depend on your treatment plan and how long you are followed up, but typically involves regular check-ups for several years.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive new or different approaches to treatment that are being carefully studied. While there's no guarantee the treatment will work for you, it could potentially help manage your cancer more effectively. However, all medical treatments carry risks of side effects, and these study treatments are no different. You might experience side effects from the drugs, some of which could be serious. Your doctors will explain all known and potential risks to you. 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.

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Unverified
Poland

Common questions

What is bevacizumab?

Bevacizumab is a type of cancer medicine that works by stopping new blood vessels from growing, which tumours need to survive. It is already used to treat various cancers.

What does 'randomised' mean in this study?

Being 'randomised' means that the treatment group you are in is chosen by chance, like drawing lots. This helps make the study fair and ensures the results are reliable.

What is a 'Phase IV' study?

A Phase IV study means the drugs being tested are already approved and in use. This study aims to learn more about the best ways to use these treatments in real-world patient care, for example, comparing different doses or combinations.

Will I know which treatment I am receiving?

This is a 'double-blind' study, which means that neither you nor your study doctors will know which specific treatment combination you are receiving. This helps prevent any bias in the study results.

How will my quality of life be checked?

You will be asked to complete standard questionnaires designed to understand how the treatment affects your daily life and well-being. This gives us important information about how people feel while on treatment.