P.J. : Emerging clinical studies will evaluate novel medical treatment approaches including the tetra-hydroisoquinoline alkaloid Yondelis (European Organisation for Research and Treatment of Cancer (EORTC) phase II trial 1320) and SMO or AKT inhibitors in molecularly selected cases.
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ClinicalTrials Identifier: NCT02234050 /// Updated: 2015_07_16 .
Descriptive Information :
Brief title : Trabectedin for Recurrent Grade II/III Meningioma .
Official title : Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group
Brief summary :
The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.
Detailed description :
This is a randomized open label multicenter comparative phase II trial.
The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.
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Recruitment Information :
Status : Recruiting
Start date : 2015-07
Primary completion date : 2017-07 (Anticipated)
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Administrative Data :
Organization name European Organisation for Research and Treatment of Cancer - EORTC
Organization study ID EORTC-1320 .
Sponsor : European Organisation for Research and Treatment of Cancer - EORTC .
Health Authority Austria: Austrian Medicines and Medical Devices Agency .
Health Authority Belgium: Federal Agency for Medicinal Products and Health Products .
Health Authority France: Committee for the Protection of Personnes .
Health Authority Germany: Paul-Ehrlich-Institut .
Health Authority Italy: The Italian Medicines Agency .
Health Authority Switzerland: Federal Office of Public Health .
Health Authority United Kingdom: Medicines and Healthcare Products Regulatory Agency .
Health Authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO).