Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Fallopian Tube Neoplasms

Adenocarcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Bevacizumab

Tin Fluorides

Rucaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Rucaparib treatment (starting dose 600 mg, twice daily) after receiving Bevacizumab for 12 to 15 months. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

Placebo treatment after receiving Bevacizumab for 12 to 15 months. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria.

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.

Placebos

Jalid Sehouli, Prof. Dr.

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.

Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients

Scienctists may submit a request for scientific use of the data after the first publication. This request shall be examined by the working group.

After signing an agreement, the anonymous data can be made available to the scientist (password protected).

time from randomization until disease progression or death

time from randomization to second progression or death

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.

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.

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".

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.

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.

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".

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients	NCT04227522	Ovarian Cancer Fallopian Tube ... Primary Periton... Clear Cell Carc...	Rucaparib Placebos	18 Years -	North Eastern German Society of Gynaecological Oncology
Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients	NCT04227522	Ovarian Cancer Fallopian Tube ... Primary Periton... Clear Cell Carc...	Rucaparib Placebos	18 Years -	North Eastern German Society of Gynaecological Oncology
Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients	NCT04227522	Ovarian Cancer Fallopian Tube ... Primary Periton... Clear Cell Carc...	Rucaparib Placebos	18 Years -	North Eastern German Society of Gynaecological Oncology

Spots Global Cancer Trial Database for brca negative