Spots Global Cancer Trial Database for Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Official Title: Niraparib vs Niraparib in Combination With Bevacizumab in Patients With Carboplatinum-taxane Based Chemotherapy in Advanced Ovarian Cancer (A Multicentre Randomised Phase III Trial)
Study ID: NCT05009082
Study Description
Brief Summary: This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.
Detailed Description: Eligible patients will be those patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III/IV, except FIGO stage IIIA2 without nodal involvement) invasive high grade epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, who have either undergone upfront primary surgery or plan to undergo chemotherapy with interval debulking surgery (IDS). In addition, patients should not have any medical contraindications that would exclude treatment with bevacizumab and/or niraparib. All eligible patients will receive the first cycle of chemotherapy (carboplatin area under curve \[AUC\] 5 and paclitaxel 175 mg/m²) as part of Study Run-In-Period (cycle 1). In parallel, central laboratory will determine the breast cancer (BRCA) status in tumor tissue (tBRCA). All patients with a valid central tBRCA test result will be randomized prior to day 1 of cycle 2 in a 1:1 ratio in the following treatment arms: Arm 1: Patients will receive further 5 cycles of carboplatin and paclitaxel q21d followed by niraparib once daily for up to a total of 3 years Arm 2: Patients will receive further 5 cycles of carboplatin and paclitaxel plus bevacizumab q21d followed by bevacizumab q21d (for up to 1 year) and niraparib once daily for up to a total of 3 years. The study aims to investigate, if the treatment strategy of carboplatin / paclitaxel / bevacizumab / niraparib is superior to the treatment of carboplatin / paclitaxel / niraparib-Inhibitor in an all-comer population.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Klinikum St. Marien Amberg, Amberg, , Germany
Hochtaunus-Kliniken, Bad Homburg, , Germany
Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, , Germany
Onkologie Bottrop (OnkoDok GbR), Bottrop, , Germany
Städt. Klinikum Brandenburg, Brandenburg an der Havel, , Germany
Klinikum Dortmund, Dortmund, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Florence-Nightingale-Krankenhaus Düsseldorf, Düsseldorf, , Germany
Universitätsfrauenklinik Düsseldorf, Düsseldorf, , Germany
KEM Essen | Evang. Kliniken Essen-Mitte gGmbH, Essen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Klinikum Frankfurt Höchst, Frankfurt/Main, , Germany
Universitätsklinikum Gießen, Gießen, , Germany
Klinikum Gütersloh, Gütersloh, , Germany
Universitätsklinikum Halle, Halle, , Germany
Albertinen Krankenhaus, Hamburg, , Germany
Mammazentrum HH am Krankenhaus Jerusalem, Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Gynäkologisch-Onkologische Praxis am Pelikanplatz, Hannover, , Germany
Universitätsklnikum Heidelberg, Heidelberg, , Germany
Klinikum am Gesundbrunnen / SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
Gyn.-onkolog. Gemeinschaftspraxis Hildesheim, Hildesheim, , Germany
Städtisches Klinikum Karlsruhe, Karlsruhe, , Germany
ViDia Christliche Kliniken Karlsruhe, Karlsruhe, , Germany
Klinikum Kassel, Kassel, , Germany
Klinikverbund Kempten-Oberallgäu gGmbH, Kempten, , Germany
Klinikum Konstanz, Konstanz, , Germany
Zentrum für ambulante gynäkologische Onkologie am HELIOS Klinikum Krefeld, Krefeld, , Germany
St. Elisabeth-Krankenhaus Köln-Hohenlind, Köln, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
St. Vincenz Krankenhaus, Limburg, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
UKSH Campus Lübeck, Luebeck, , Germany
Universitätsmedizin Mainz, Mainz, , Germany
Universitätsklinikum Mannheim GmbH, Mannheim, , Germany
Mühlenkreiskliniken, Johannes Wesling Klinikum Minden, Minden, , Germany
LMU Klinikum München-Großhadern, München, , Germany
Rotkreuzklinikum München, München, , Germany
Universitätsklinikum Münster, Münster, , Germany
Klinikum Neumarkt, Neumarkt, , Germany
MVZ Nordhausen, Nordhausen, , Germany
Klinikum Offenbach, Offenbach, , Germany
Ortenau Klinikum Offenburg-Kehl, Offenburg, , Germany
St. Vincenz Krankenhaus GmbH, Paderborn, , Germany
Studienzentrum Onkologie Ravensburg, Ravensburg, , Germany
Krankenhaus Barmherzige Brüder, Regensburg, , Germany
Klinikum am Steinenberg, Reutlingen, , Germany
RoMed Klinikum Rosenheim, Rosenheim, , Germany
Klinikum Südstadt Rostock, Rostock, , Germany
Thüringen-Kliniken "Georgius Agricola", Saalfeld, , Germany
Leopoldina Krankenhaus Schweinfurt, Schweinfurt, , Germany
g.SUND, Stralsund, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Klinikum Traunstein, Traunstein, , Germany
Klinikum Mutterhaus, Trier, , Germany
Universitätsklinikum Tübingen, Tuebingen, , Germany
Universitätsklinik Ulm, Ulm, , Germany
St. Josefs-Hospital, Wiesbaden, , Germany
amO Wolfsburg, Wolfsburg, , Germany
Klinikum Worms, Worms, , Germany
Contact Details
Name: Philipp Harter, MD, PhD
Affiliation: KEM Essen | Evang. Kliniken Essen-Mitte gGmbH
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
