Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal

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What is this study about?

This clinical trial is focused on studying the treatment of advanced high-grade ovarian cancer, including related conditions such as fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary. The study involves patients who have no remaining tumor mass after initial surgery. The treatment being tested is a medication called niraparib tosylate monohydrate, which is taken as a tablet. This medication is being compared to standard chemotherapy treatments, which include carboplatin and paclitaxel, both given as infusions through a vein.

The purpose of the study is to determine if taking niraparib after three cycles of chemotherapy is as effective as taking it after six cycles. The study will involve patients receiving either three or six cycles of chemotherapy, followed by maintenance treatment with niraparib. Some patients may receive a placebo instead of niraparib to compare the outcomes. The study aims to see if the shorter treatment duration can provide similar benefits in preventing cancer from returning.

Participants in the study will be monitored over time to assess their health and any side effects from the treatments. The study will also look at how long patients live without the cancer coming back and their overall survival rates. The trial will help determine the best approach to using niraparib in treating these types of cancer, potentially offering a more efficient treatment option for patients in the future.

1 joining the study

Upon joining the study, the patient will be informed about the trial and will provide written consent to participate.

The patient must meet specific criteria, such as being postmenopausal or having a non-childbearing status, and must be able to take oral medications.

2 initial chemotherapy cycles

The patient will undergo three cycles of chemotherapy, which includes the administration of carboplatin and paclitaxel through intravenous routes.

Each cycle will be followed by a medical evaluation to monitor the patient’s response to the treatment.

3 maintenance therapy with niraparib

After completing the initial chemotherapy cycles, the patient will begin maintenance therapy with niraparib tosilate monohydrate, taken orally in tablet form.

The dosage and frequency of niraparib will be determined by the medical team based on the patient’s condition and response to previous treatments.

4 additional chemotherapy cycles (if applicable)

If required, the patient may undergo an additional three cycles of chemotherapy with carboplatin and paclitaxel administered intravenously.

The decision for additional cycles will be based on the patient’s medical evaluation and the study’s protocol.

5 ongoing monitoring and assessments

Throughout the trial, the patient will have regular assessments to monitor recurrence-free survival and overall health.

These assessments will include laboratory evaluations, vital signs, and physical examinations to ensure the patient’s safety and well-being.

6 completion of the trial

The trial is expected to continue until March 31, 2032, with ongoing monitoring and data collection.

Upon completion, the patient’s overall survival and response to the treatment will be evaluated to determine the effectiveness of the therapy.

Who Can Join the Study?

You must provide written informed consent before any study-related procedures are done.
You must be a woman who is either postmenopausal or not able to have children. If you can have children, you need to have a negative pregnancy test before starting the study treatment.
You must be 18 years of age or older.
You must have advanced high-grade ovarian cancer, which is a specific type of cancer, but not the mucinous type.
You must have had surgery to remove the primary tumor, and a CT scan must confirm that no visible tumor remains.
You must have tumor samples available for special testing to confirm a specific genetic status called HRD positive.
Your general health must be good, as measured by a performance status of 0 or 1 on a specific scale called the ECOG performance status.
You must be able to take medications by mouth.
If you have other cancers, they are allowed as long as they do not affect the outlook of your ovarian cancer. The study team must be informed before you join the trial.
Your organs and bone marrow must be functioning normally, which includes:
- Hemoglobin levels of at least 10.0 g/dL without needing a blood transfusion recently.
- A certain type of white blood cell count, called absolute neutrophil count, must be at least 1.5 x 10⁹/L.
- Platelet count must be at least 100 x 10⁹/L.
- Total bilirubin, a liver function measure, must be within normal limits, except in certain conditions like Gilbert’s syndrome.
- Liver enzymes, called ASAT/SGOT and ALAT/SGPT, must be within 2.5 times the normal limit.
- Serum creatinine, a kidney function measure, must be within normal limits, and creatinine clearance must be over 30 mL/min.

Who Cannot Join the Study?

Patients with any other type of cancer that is not specified in the study.
Patients who have not undergone surgery to remove the primary tumor.
Patients with remaining tumor mass after surgery.
Patients who have not been diagnosed with the specific types of cancer mentioned in the study.
Patients who are male, as the study is only for female patients.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Hospital Jena KöR	Jena	Germany
DRK Kliniken Berlin	Berlin	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Klinikum Dortmund gGmbH	Dortmund	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Fakultni Nemocnice Bulovka	Prague	Czechia
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Christliches Klinikum Unna gGmbH	Unna	Germany
Diakonie-Klinikum Schwaebisch Hall gGmbH	Schwäbisch Hall	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Universita’ Di Pisa	Pisa	Italy
Alessandro Manzoni Hospital	Lecco	Italy
Hospital General Universitario De Valencia	Valencia	Spain
Kaiserswerther Diakonie	Duesseldorf	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Jessa Ziekenhuis	Hasselt	Belgium
Hospital Universitario Lucus Augusti	Lugo	Spain
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Salut Sant Joan De Reus	Reus	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Hospital Ostrava	Ostrava	Czechia
Schwesternschaft Der Krankenfuersorge Des Dritten Ordens KdöR	Munich	Germany
Cpqcplmsn Upmrtcnnsnquoh Satlpfzum	Woluwe-Saint-Lambert	Belgium
Hhkcgc Dgl Hgtpm Snevilk Kroqndle Wrxhxhdnl Gecb	Wiesbaden	Germany
Kmwbhrja Lbqvv Gesk	Detmold	Germany
Uvgiyqqwil Muqozei Chgogv Hquncpzmxbbymcoqv	Hamburg	Germany
Zvdvbrw fom aikbzkgtp Htmifxvjkce ulv Ohfnlvepv	Bonn	Germany
Kcywnhvy Mjgvlddgqxx Byhl	Baden-Baden	Germany
Uqpsnzmmpo Hufxnhif Cvoqrob	Cologne	Germany
Aqollcz Onxtuarpnqk Uxuecynuueoot Cqitvmugkpdy Dgyea Scbubu E Ddile Sqhrhak Dc Tjsvcr	Turin	Italy
Aazftyd Ukf Iafjf Du Reizxv Ehuddo	Reggio Emilia	Italy
Argqcmx Uqhra Sftdqyrlz Lfeaoq Dj Bkbtbsp	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.01.2024
Belgium	Recruiting	01.01.2024
Czechia	Recruiting	01.01.2024
Germany	Recruiting	01.01.2024
Italy	Recruiting	01.01.2024
Spain	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Niraparib is a medication used in this clinical trial as a maintenance therapy for patients with advanced high-grade ovarian cancer. It is given to patients after they have completed their initial chemotherapy treatment. The goal of using niraparib is to help prevent the cancer from coming back and to extend the time patients remain free from cancer recurrence.

Investigated diseases:

High-Grade Ovarian Cancer – This is a type of cancer that originates in the ovaries and is characterized by rapidly growing, abnormal cells. It is often diagnosed at an advanced stage, such as stage III or IV, according to the FIGO classification. The disease can spread to nearby tissues and organs, including the fallopian tubes and peritoneum. High-grade ovarian cancer is often associated with genetic mutations, such as HRD positivity, which can influence its behavior and progression. The cancer may initially respond to treatment, but there is a risk of recurrence.

Fallopian Tube Cancer – This rare cancer begins in the fallopian tubes, which connect the ovaries to the uterus. It shares similarities with ovarian cancer in terms of symptoms and progression. The disease can spread to nearby organs and tissues, including the ovaries and peritoneum. It is often detected at an advanced stage, making it challenging to manage. The cancer may initially respond to treatment, but recurrence is possible.

Primary Peritoneal Cancer – This cancer originates in the peritoneum, the lining of the abdominal cavity, and is similar to ovarian cancer in its behavior and progression. It can spread to nearby organs and tissues, including the ovaries and fallopian tubes. The disease is often diagnosed at an advanced stage, which can complicate management. Primary peritoneal cancer may initially respond to treatment, but there is a risk of recurrence.

Clear Cell Carcinoma of the Ovary – This is a subtype of ovarian cancer characterized by the presence of clear cells when viewed under a microscope. It is known for its distinct cellular appearance and can behave differently from other types of ovarian cancer. The disease can spread to nearby tissues and organs, including the fallopian tubes and peritoneum. Clear cell carcinoma is often diagnosed at an advanced stage, which can affect its management. The cancer may initially respond to treatment, but recurrence is possible.

Trial ID:

2022-502559-69-01

Protocol code:

NOGGO-ov53

NCT ID:

NCT05460000

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal

What is this study about?

Who Can Join the Study?

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