Comparison of Niraparib alone versus Niraparib with Bevacizumab in patients with newly diagnosed advanced ovarian cancer after chemotherapy with carboplatin and paclitaxel
This clinical trial focuses on patients with newly diagnosed advanced ovarian cancer, peritoneal cancer, or fallopian tube cancer. The study compares two treatment approaches using several medications. All patients will initially receive chemotherapy with carboplatin and paclitaxel, which are standard cancer drugs given through an intravenous infusion.
After the initial chemotherapy, patients will be divided into two groups. One group will receive a medication called niraparib alone, while the other group will receive niraparib combined with bevacizumab. Niraparib is taken as a capsule by mouth, while bevacizumab is given through an intravenous infusion. The purpose of this study is to determine if adding bevacizumab to niraparib treatment leads to better results than using niraparib alone.
The study will monitor how long patients remain without their cancer getting worse. Patients will receive regular medical examinations and tests throughout the study period. The treatment may continue for up to 36 months, depending on how well patients respond to the therapy and whether they experience any side effects.
1Initial chemotherapy phase
You will receive a combination of paclitaxel and carboplatin through intravenous infusion
During this phase, some patients will also receive bevacizumab through intravenous infusion
The treatment will begin within 8 weeks after surgery
2Maintenance treatment phase
After completing chemotherapy, you will receive niraparib capsules taken by mouth
Some patients will continue receiving bevacizumab through intravenous infusion along with niraparib
The specific treatment group will be determined randomly
3Regular monitoring
Your health will be monitored through regular medical examinations
Blood tests will check your liver and kidney function
Blood pressure measurements will be taken regularly
Imaging tests will be performed to assess the cancer’s response to treatment
4Quality of life assessment
You will be asked to complete questionnaires about your symptoms and quality of life
These assessments help monitor how the treatment affects your daily life
5Long-term follow-up
Your progress will be monitored until 2031
Regular check-ups will continue to assess your response to treatment
Any side effects or health changes will be documented and managed
Who Can Join the Study?
Must be female and at least 18 years old
Must have been diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer that has been confirmed through tissue examination
Must have either already had initial surgery or be planning to have chemotherapy followed by surgery
Must be able to start treatment within 8 weeks after surgery
Must have good physical function (able to carry out all normal activities with minimal limitations)
Must have a life expectancy of more than 3 months
Must have adequate blood test results showing:
– Normal liver and kidney function
– Good blood cell counts
– Normal blood clotting ability
Must have normal blood pressure or well-controlled blood pressure (140/90 or lower)
Must provide a tissue sample for BRCA genetic testing
For women who can become pregnant:
– Must have a negative pregnancy test
– Must use highly effective birth control or remain abstinent during treatment and for 6 months after
Must be willing and able to:
– Attend scheduled appointments
– Follow treatment plans
– Complete required laboratory tests
– Fill out questionnaires
Must sign an informed consent form showing understanding of and willingness to participate in the study
Who Cannot Join the Study?
Prior chemotherapy, radiotherapy, hormonal therapy, immunotherapy, or any other systemic anti-cancer treatment for ovarian cancer
History of other cancers within the last 5 years (except successfully treated non-melanoma skin cancer or cervical carcinoma in situ)
Known brain metastases (cancer that has spread to the brain)
Significant cardiovascular disease, including:
Uncontrolled high blood pressure
Heart attack within past 6 months
Unstable angina (chest pain)
Severe heart rhythm problems
Major surgery within 4 weeks before starting treatment
Active bleeding or high risk of bleeding
Serious infections requiring antibiotics
Pregnancy or breastfeeding
Known allergies to any of the study medications
Inability to swallow oral medications
Serious medical conditions that could interfere with study participation
Thromboembolism (blood clots) within the past 6 months
Inadequate organ function, including:
Poor kidney function
Poor liver function
Low blood cell counts
Psychiatric disorders or conditions that would interfere with following study requirements
Niraparib is a medication that belongs to a class of drugs called PARP inhibitors. It works by blocking an enzyme that cancer cells need to repair their DNA, which can help stop cancer cells from growing. It is taken as an oral medication and is used in the treatment of ovarian cancer.
Bevacizumab is a targeted therapy that works by blocking the formation of new blood vessels that feed tumors. It belongs to a class of drugs called angiogenesis inhibitors. This medication is given through an intravenous (IV) infusion and helps prevent tumors from growing by cutting off their blood supply.
Carboplatin is a chemotherapy medication that belongs to a group of drugs called platinum compounds. It works by interfering with cancer cell DNA, preventing cancer cells from dividing and growing. It is given through an intravenous (IV) infusion.
Paclitaxel is a chemotherapy medication that belongs to a class of drugs called taxanes. It works by stopping cancer cells from dividing and growing. This medication is given through an intravenous (IV) infusion and is commonly used in combination with other cancer treatments.
Ovarian Cancer – A disease that begins in the ovaries when cells start growing abnormally. It typically develops in the cells that make up the outer surface of the ovary. The cancer can spread within the pelvis and abdomen.
Peritoneal Cancer – A rare cancer that develops in the peritoneum, the thin layer of tissue that lines the abdomen and covers most of the abdominal organs. It behaves similarly to ovarian cancer and produces similar symptoms.
Fallopian Tube Cancer – A disease that begins in the fallopian tubes, which connect the ovaries to the uterus. The cancer starts in the cells of the fallopian tube lining and can spread to nearby organs. This type of cancer is closely related to ovarian cancer in terms of its behavior and characteristics.
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