IRINA

{ "short_title": "IRINA", "data_mode": "900", "data_mode_number": "000002051", "official_title": "Influence of Radiation on Immune respoNse to checkpoint blocker treatment in patients with metastasized melanomA", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "adjuvant", "therapielinie_value": "first", "ctgov_number": null, "eudract_number": null, "general_contact_email": "str.studien@uniklinikum-dresden.de", "general_contact_phone": "+49 351-4582238", "hauptpruefer_dd_name": "Prof. Dr. med. Dr. Esther Troost", "description_laie_de": "Eine nicht-interventionelle, prospektive, randomisierte, multizentrische Studie mit dem Ziel den Einfluss des Zeitpunktes der Bestrahlung auf die Immunantwort in Patienten mit metastasiertem Melanom zu untersuchen.", "description_laie_en": "The aim of the study is to evaluate the influence of timing of radiotherapy, i.e., to detect potential beneficial immune modulatory effects of radiotherapy affecting disease outcome in patients with metastatic melanoma. The primary endpoint will be the influence of early irradiation on progression free survival (PFS), and in case a positive effect is found, in a second step (co-primary endpoint), the overall response rate (ORR) to radiotherapy as a function of timing.", "description_expert_de": "Eine nicht-interventionelle, prospektive, randomisierte, multizentrische Studie mit dem Ziel den Einfluss des Zeitpunktes der Bestrahlung auf die Immunantwort in Patienten mit metastasiertem Melanom zu untersuchen.", "description_expert_en": "The aim of the study is to evaluate the influence of timing of radiotherapy, i.e., to detect potential beneficial immune modulatory effects of radiotherapy affecting disease outcome in patients with metastatic melanoma. The primary endpoint will be the influence of early irradiation on progression free survival (PFS), and in case a positive effect is found, in a second step (co-primary endpoint), the overall response rate (ORR) to radiotherapy as a function of timing.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 5, "sub_cat_id": 35 }