AGO-Ovar 27

Section NCT
Category Gynecological tumors / Breast cancer
Subcategory Ovarian cancer
Trial Type First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts Window-of-opportunity proof-of-concept, non-randomized, openlabel phase II trial of Olaparib given alone (cohort A) or in combination with Durvalumab (cohort B) prior to primary debulking surgery in histologically proven high-grade epithelial ovarian cancer (EOC)
Description for laymen Window-of-opportunity proof-of-concept, non-randomized, openlabel phase II trial of Olaparib given alone (cohort A) or in combination with Durvalumab (cohort B) prior to primary debulking surgery in histologically proven high-grade epithelial ovarian cancer (EOC)
JSON Data { "short_title": "AGO-Ovar 27", "data_mode": "900", "data_mode_number": "000002360", "official_title": "WoO: Window of Opportunity (\u00e2??Gelegenheitsfenster\u00e2??) Studie zu Olaparib und Durvalumab in histologisch nachgewiesenem EOC", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "first", "ctgov_number": null, "eudract_number": "2020-005101-12", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Es handelt sich um eine nichtrandomisierte, open-label Phase II Studie, in der die Machbarkeit einer Behandlung mit Olaparib als Monotherapie oder in Kombination mit Durvalumab w\u00e4hrend des Zeitfensters (\u201eWindow-of-Opportunity\u201c) zwischen der Verdachtsdiagnose bzw. der diagnostischen Bauchspiegelung und der prim\u00e4ren Operation zur Tumorentfernung untersucht wird. Dar\u00fcber hinaus soll untersucht werden, ob \u00c4nderungen im Profil der zirkulierenden Tumor-DNA (ctDNA) w\u00e4hrend dieser Behandlungsphase zur Vorhersage einer zielgerichteten Therapie f\u00fcr individuelle Patientinnen geeignet sind.", "description_laie_en": "Window-of-opportunity proof-of-concept, non-randomized, open\u0002label phase II trial of Olaparib given alone (cohort A) or in \r\ncombination with Durvalumab (cohort B) prior to primary debulking \r\nsurgery in histologically proven high-grade epithelial ovarian \r\ncancer (EOC)", "description_expert_de": "Window-of-opportunity \u2013 AGO-OVAR 27 ist eine nichtrandomisierte, open-label Phase Machbarkeitsstudie zur Verabreichung von Olaparib als Monotherapie (Kohorte A) oder in Kombination mit Durvalumab (Kohorte B) vor der prim\u00e4ren Tumordebulking-Operation beim histologisch nachgewiesenen hochgradigen epithelialen Ovarialkarzinom (EOC).", "description_expert_en": "Window-of-opportunity proof-of-concept, non-randomized, open\u0002label phase II trial of Olaparib given alone (cohort A) or in \r\ncombination with Durvalumab (cohort B) prior to primary debulking \r\nsurgery in histologically proven high-grade epithelial ovarian \r\ncancer (EOC)", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 3, "sub_cat_id": 15 }
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Short name 900-000002360