N-Plus

{ "short_title": "N-Plus", "data_mode": "900", "data_mode_number": "000002431", "official_title": "Die N-PLUS-Studie (A Phase II randomized, open label non-inferiority study of NiraParib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completeLy debUlked advanced HRDpositive high-grade ovarian cancer patientS in first line therapy) wird im Rahmen des Europ\u00e4ischen Studiennetzwerks ENGOT (European Network for Gynaecological Oncological Trial Groups) durchgef\u00fchrt.", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "second", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Eine randomisierte, offene Nichtunterlegenheitsstudie der Phase II zur NiraParib-Erhaltungstherapie nach 3 vs. 6 Zyklen einer Chemotherapie auf Platinbasis bei Patientinnen mit vollst\u00e4ndig debulkiertem fortgeschrittenem HRD-positivem hochgradigem Eierstockkrebs in der Erstlinientherapie", "description_laie_en": "A Phase II randomized, open label non-inferiority study of NiraParib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completeLy debUlked advanced HRDpositive high-grade ovarian cancer patientS in first line therapy", "description_expert_de": "Eine randomisierte, offene Nichtunterlegenheitsstudie der Phase II zur NiraParib-Erhaltungstherapie nach 3 vs. 6 Zyklen einer Chemotherapie auf Platinbasis bei Patientinnen mit vollst\u00e4ndig debulkiertem fortgeschrittenem HRD-positivem hochgradigem Eierstockkrebs in der Erstlinientherapie", "description_expert_en": "A Phase II randomized, open label non-inferiority study of NiraParib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completeLy debUlked advanced HRDpositive high-grade ovarian cancer patientS in first line therapy", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 3, "sub_cat_id": 15 }