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Brief Title: Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients
Official Title: Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients
Study ID: NCT04227522
Brief Summary: MAMOC is a multicenter, randomized, placebo controlled, double blind study including BRCA negative patients with histologically confirmed, advanced (FIGO stage IIIA, IIIB, IIIC, or IV of the 2014 FIGO classification) high grade serous or high grade endometrioid (based on local histopathological findings) ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary in first line therapy.
Detailed Description: The main scope of this trial is to determine progression free survival in BRCA negative patients treated with Rucaparib as maintenance therapy vs. Placebo after receiving Bevacizumab for 12 to 15 months. BRCA negative patients will be stratified according to time point of surgery (adjuvant vs. neoadjuvant), result of surgery (tumor free vs. not tumor free resection), study site and response (complete response (CR) vs. partial response (PR)/SD) and randomized 2:1 to receive either Rucaparib (Arm A) or Placebo (Arm B). In both of the arms, tumor assessments (CT or MRI) are performed before randomization, and every 6 months thereafter. During treatment, clinical visits (blood cell counts, detection of toxicity) occur every 4 weeks. Physical examinations will take place every 12 weeks. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs). About 30 sites in Germany will participate in this study to recruit 190 BRCA negative patientsin 24 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Universitätsklinikum Aachen, Aachen, , Germany
ANregiomed Frauenklinik Ansbach, Ansbach, , Germany
Helios Klinikum Berlin-Buch, Berlin, , Germany
CharitÊ - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Städtisches Klinikum Dessau, Dessau, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Kliniken Essen Mitte, Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken g AG, Karlsruhe, , Germany
Städtisches Krankenhaus Kiel, Kiel, , Germany
ZAGO-Zentrum fßr ambulante gynäkologische Onkologie, Krefeld, , Germany
Universitätsklinikum Mannheim, Mannheim, , Germany
LMU Klinikum GroĂhadern, MĂźnchen, , Germany
Universitätsklinikum Mßnster, Mßnster, , Germany
CaritasKlinikum SaarbrĂźcken, SaarbrĂźcken, , Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, , Germany
Name: Jalid Sehouli, Prof. Dr.
Affiliation: CharitÊ - Universitätsmedizin Berlin, Campus Virchow Klinikum
Role: PRINCIPAL_INVESTIGATOR