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RecruitingPHASE3INTERVENTIONAL

Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer

This study looks at new treatments for advanced ovarian, fallopian tube, or peritoneal cancers. Patients will receive standard chemotherapy (carboplatin and paclitaxel). Then, some will get a maintenance treatment with niraparib, while others will receive bevacizumab and niraparib. The main goal is to find out if adding bevacizumab to niraparib and standard chemotherapy is more effective in keeping the cancer under control for longer. This is a Phase 3 trial, meaning it's testing new treatments after they've shown promise in earlier stages, to see how they compare to existing care. It's open to newly diagnosed patients who have had or will have surgery.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AGO Study Group
Enrolment target
970
Start
13 Sep 2022
Estimated completion
01 Dec 2031

What is this study about?

This study is for people who have been diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer. These cancers are often treated with surgery and chemotherapy. This trial wants to see if adding certain medications after standard chemotherapy can help prevent the cancer from coming back or growing for longer.

Imagine you have a garden, and some weeds (cancer cells) have grown. You pull out the big weeds (surgery) and then use a general weed killer (chemotherapy) to get rid of more. This study is like trying two different longer-term weed prevention methods. One group of patients will receive a medicine called niraparib. The other group will receive both niraparib and another medicine called bevacizumab. Scientists want to understand if one of these prevention methods works better than the other.

The study will involve patients from different countries. By comparing two different treatment plans, the researchers hope to find the best way to help people with these types of cancer live longer and healthier lives. It's an important step in finding improved treatments.

Key takeaways

  • This study compares two ways to treat advanced ovarian, fallopian tube, or peritoneal cancer.
  • It tests if adding an extra drug (bevacizumab) to standard treatment and niraparib is more effective.
  • Patients receive chemotherapy first, then are randomly assigned to one of two maintenance treatment plans.
  • The study involves regular hospital visits, blood tests, and follow-up.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be a woman aged 18 or older with newly diagnosed advanced ovarian, fallopian tube, or peritoneal cancer. This includes certain stages of the cancer (FIGO stage III/IV) that haven't spread too widely.

You must have already had surgery to remove as much of the cancer as possible, or be scheduled to have surgery after starting chemotherapy. Your cancer cells will also be tested to check for specific genetic changes before you can join the main part of the study. You'll need to be in reasonably good general health, meaning you can do light daily activities and your blood tests show your body is working well enough to handle the treatments.

There are also some medical conditions or past treatments that might mean this study isn't right for you, especially if you can't safely take the medicines being tested. Your doctor will carefully review all your medical information to see if you meet all the 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.

  1. Are you a woman aged 18 or older?
  2. Have you been recently diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer?
  3. Have you had surgery for your cancer, or plan to have it soon after starting chemotherapy?
  4. Are you generally well enough to manage daily activities?
  5. Do you not have any other major medical conditions that would prevent you from taking these specific study medications?
Answer every question to see your result.

What does participation involve?

If you decide to join, the study starts with one cycle of standard chemotherapy (carboplatin and paclitaxel). During this time, a small piece of your cancer tissue will be sent for special tests to look at your `BRCA` gene. Based on these results, you'll be randomly assigned to one of two treatment groups – like flipping a coin, so it's fair. You will then receive five more cycles of chemotherapy. One group will get these with bevacizumab, and the other won't.

After chemotherapy, your treatment continues for up to three years. One group will take niraparib daily. The other group will take niraparib daily AND receive bevacizumab injections every three weeks for up to a year. You'll have regular hospital visits for treatments, blood tests, and check-ups to see how you're doing and how the treatment is working. The total duration of active treatment will vary depending on the group you're in, but follow-up could continue for several years.

Potential risks and benefits

Taking part in a clinical trial might mean you receive a new treatment that could be more effective than standard care. Researchers are hoping that adding these medicines will help keep your cancer under control for longer. However, there are no guarantees, and these treatments can have side effects, some of which might be serious. Your doctors will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (65)

  • Klinikum St. Marien Amberg
    Verified postcode
    Amberg, Germany· Recruiting
  • Klinikum Augsburg
    Verified postcode
    Augsburg, Germany· Recruiting
  • Hochtaunus-Kliniken
    Verified postcode
    Bad Homburg, Germany· Recruiting
  • Helios Klinikum Berlin-Buch
    Verified postcode
    Berlin, Germany· Recruiting
  • Onkologische Schwerpunktpraxis Bielefeld
    Verified postcode
    Bielefeld, Germany· Recruiting
  • Städt. Klinikum Brandenburg
    Verified postcode
    Brandenburg an der Havel, Germany· Recruiting
  • Klinikum Bremen Mitte
    Verified postcode
    Bremen, Germany· Recruiting
  • Klinikum Chemnitz
    Verified postcode
    Chemnitz, Germany· Recruiting
  • St. Elisabeth-Krankenhaus Köln-Hohenlind
    Verified postcode
    Cologne, Germany· Recruiting
  • Klinikum Dortmund
    Verified postcode
    Dortmund, Germany· Recruiting
  • Universitätsklinikum Carl Gustav Carus Dresden
    Verified postcode
    Dresden, Germany· Recruiting
  • Florence-Nightingale-Krankenhaus Düsseldorf
    Verified postcode
    Düsseldorf, Germany· Not yet recruiting

Common questions

What type of cancer is this study for?

This study is for newly diagnosed advanced ovarian, fallopian tube, or peritoneal cancer.

What are the main treatments being compared?

The study compares standard chemotherapy plus niraparib versus standard chemotherapy plus both niraparib and bevacizumab.

Will I know which treatment I am getting?

Yes, this is an 'open' study, meaning you will know which treatment plan you are on after you've been assigned to a group.

How long will I be in the study?

The active treatment phase could last up to three years, with regular check-ups and monitoring during that time.

What is the purpose of testing my cancer tissue?

Testing your cancer tissue, specifically for the 'BRCA' gene, helps researchers understand how different cancer types respond to treatment and guides your treatment group assignment.

How to find out more

Sandra Polleis

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

Interested in taking part?

Register your interest

Share your details and the research team for "Niraparib vs Niraparib Plus Bevacizumab in Patients With Pla…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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