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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
A starting dose of 600 mg Rucaparib is taken twice daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
Placebo is taken daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
Universitätsklinikum Aachen
Aachen, Germany
ANregiomed Frauenklinik Ansbach
Ansbach, Germany
Helios Klinikum Berlin-Buch
Berlin, Germany
Charité - 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
...and 7 more locations
Progression free survival (PFS)
time from randomization until disease progression or death
Time frame: 48 months
Progression free survival 2 (PFS2)
time from randomization to second progression or death
Time frame: 48 months
Quality of Life (QoL) 1
Patients are asked to answer the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). Responses of questions 1-28 are based on a 4-point scale (1=not at all; 4=Very much), with a higher score indicating a high degree of symptomatology and must therefore be assessed negatively. Responses of questions 29 and 30 are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status.
Time frame: 48 months
Quality of Life 2
Patients are asked to answer the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28). Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better symptoms.
Time frame: 48 months
Quality of Life/ Global health status 3
Patients are asked to answer the short version of the SF-36 Health Survey (SF-12). The questionnaire contains a total of 12 questions with different response options. For questions 1, 8 and 12 there are 5 (1=excellent, 5=bad), for question 2-3 there are 3 (1=yes, very restricted, 3=no, not restricted at all) and for questions 9-11 there are 6 response options (1= always, 6 = never). Questions 4-7 can be answered with "Yes" or "No".
Time frame: 48 months
Quality of Life 4
Patients are asked to answer the questionnaire Fatigue Symptom Inventory (FSI). Responses are based on a 10 point grading scale (0=not at all tired/ exhausted; 10=completely tired/ exhausted), with a lower score indicating a lower symptomatology of fatigue.
Time frame: 48 months
Quality of Life 5
Patients are asked to answer the Everyday Memory Questionnaire. Responses are based on a 5-point scale (1=occasionally; 5=very often), with a lower score indicating a better performance on memory associated Everyday activities.
Time frame: 48 months
Quality of Life 6
Patients are asked to answer a custom form of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events developed by the National Cancer Institute (NCI PRO-CTCAE™) Version 1.0. The frequency and strength of symptoms is queried. There are 5 possible answers: "not at all", "a little", "moderate", "quite", "very".
Time frame: 48 months
Determination of time to next medical intervention
(e.g. bowel obstruction, Ascites puncture)
Time frame: 48 months
Time to next subsequent therapy
e.g. chemotherapy
Time frame: 48 months
Number of participants with treatment-related adverse events and/or serious adverse events as assessed by CTCAE v4.03
AEs/SAEs
Time frame: 48 months
Overall survival (OS)
defined as time from Randomization to death by any cause
Time frame: 72 months
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