<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234050</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1320-BTG</org_study_id>
    <secondary_id>2014-002446-47</secondary_id>
    <nct_id>NCT02234050</nct_id>
  </id_info>
  <brief_title>Trabectedin for Recurrent Grade II/III Meningioma</brief_title>
  <official_title>Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to collect data on activity, toxicity and quality of life of&#xD;
      trabectedin therapy in patients with recurrent high-grade meningioma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized open label multicenter comparative phase II trial. The objective of the&#xD;
      study is to investigate whether trabectedin demonstrates sufficient antitumor activity&#xD;
      against recurrent grade II or III to justify further investigation in phase III or as&#xD;
      adjuvant therapy for newly diagnosed disease after resection and radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">January 16, 2019</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival at 6 months (PFS-6), median PFS (mPFS)</measure>
    <time_frame>From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration.</measure>
    <time_frame>From the date of randomization until disease progression</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)</measure>
    <time_frame>From the date of randomization up to the date of death, up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety (CTCAE v.4.0)</measure>
    <time_frame>From randomization up to 30 days after administration of the last dose of protocol treatment or until the start of a new antitumor therapy, whichever occurs first.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of life (HRQol)</measure>
    <time_frame>Untill six months after randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Recurrent High Grade Meningioma</condition>
  <arm_group>
    <arm_group_label>Trabectedin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be treated with trabectedin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trabectedin</intervention_name>
    <description>Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.</description>
    <arm_group_label>Trabectedin</arm_group_label>
    <other_name>Yondelis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Local standard of care</intervention_name>
    <description>Left to the discretion of the investigator</description>
    <arm_group_label>Local standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient selection criteria&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Histological diagnosis of WHO grade II (chordoid meningioma, clear cell meningioma,&#xD;
             atypical meningioma) or WHO grade III (papillary meningioma, rhabdoid meningioma,&#xD;
             anaplastic/malignant meningioma) according to WHO 2007 classification.&#xD;
&#xD;
          -  Radiologically documented progression of any existing tumor (growth &gt; 25% in the last&#xD;
             year) or appearance of new lesions (including intra- and extracranial manifestations)&#xD;
&#xD;
          -  No more option for local therapy (resection or radiotherapy) after maximal feasible&#xD;
             surgery and radiotherapy&#xD;
&#xD;
          -  No prior systemic anti-neoplastic therapy for meningioma&#xD;
&#xD;
          -  Measurable disease (10 x10 mm) on cranial MRI no more than 2 weeks prior to&#xD;
             randomization.&#xD;
&#xD;
          -  WHO performance status 0-2&#xD;
&#xD;
          -  Adequate liver, renal and hematological function within 4 weeks prior to&#xD;
             randomization, defined as:&#xD;
&#xD;
               -  Neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL or hemoglobin ≥ 5.6 mmol/L,&#xD;
                  platelets ≥ 100 x 109/L&#xD;
&#xD;
               -  Total Bilirubin ≤ 1 x ULN, SGPT/ALT and SGOT/AST ≤ 2.5 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 x ULN; if alkaline phosphatase &gt; 2.5 ULN, ALP hepatic&#xD;
                  isoenzyme and/or 5-nucleotidase and/or gamma glutyamyltransferase (GGT) must be&#xD;
                  within the normal range&#xD;
&#xD;
               -  Albumin ≥ 30 g/L&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x ULN&#xD;
&#xD;
               -  Creatinine clearance &gt; 30 ml/min as calculated by Cockcroft and Gault formula&#xD;
                  (see Appendix E)&#xD;
&#xD;
               -  Creatine phosphokinase (CPK) ≤ 2.5 x ULN&#xD;
&#xD;
          -  Normal cardiac function (LVEF assessed by MUGA or ECHO within normal range of the&#xD;
             institution), normal 12 lead ECG (without clinically significant abnormalities). The&#xD;
             following unstable cardiac conditions are not allowed:&#xD;
&#xD;
               -  Congestive heart failure&#xD;
&#xD;
               -  Angina pectoris&#xD;
&#xD;
               -  Myocardial infarction within 1 year before registration/randomization&#xD;
&#xD;
               -  Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mm Hg&#xD;
                  despite optimal medical therapy&#xD;
&#xD;
               -  Arrhythmias clinically significant&#xD;
&#xD;
          -  Life expectancy of at least 9 weeks&#xD;
&#xD;
          -  No history of any other invasive malignancy within the last 5 years (except adequately&#xD;
             treated non-melanoma skin cancer, clinicaly localized and very low risk prostate&#xD;
             cancer, and adequately treated cervical intraepithelial neoplasia)&#xD;
&#xD;
          -  No serious illness or medical conditions, specifically: active infectious process;&#xD;
             chronic active liver disease, including chronic hepatitis B, C or cirrhosis&#xD;
&#xD;
          -  No concomitant use of any other investigational agent or phenytoin&#xD;
&#xD;
          -  Women of child bearing potential (WOCBP) must have a negative serum (or urine)&#xD;
             pregnancy test within 72 hours prior to the first dose of study treatment. Women of&#xD;
             childbearing / reproductive potential should use adequate birth control measures, as&#xD;
             defined by the investigator, during the study treatment period and for at least 3&#xD;
             months after the last study treatment. Men who are fertile must use effective&#xD;
             contraception during treatment with trabectedin and for 5 months thereafter. A highly&#xD;
             effective method of birth control is defined as one that results in low failure rate,&#xD;
             i.e. less than 1% per year, when used consistently and correctly.&#xD;
&#xD;
          -  Female subjects who are breastfeeding should discontinue nursing prior to the first&#xD;
             dose of study treatment and until 3 months after the last study treatment.&#xD;
&#xD;
          -  No known MRI or CT, including contrast media, contraindications&#xD;
&#xD;
          -  Absence of any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule; those&#xD;
             conditions should be discussed with the patient before registration in the trial&#xD;
&#xD;
          -  Patients with a buffer range from the normal values of +/- 5 % for hematology and +/-&#xD;
             10% for biochemistry are acceptable. A maximum of +/- 2 days for timelines may be&#xD;
             acceptable&#xD;
&#xD;
          -  Before patient randomization, written informed consent must be given according to&#xD;
             ICH/GCP, and national/local regulations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Preusser</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University Vienna - General Hospital AKH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Landesnervenklinik Wagner Jauregg</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Vienna - General Hospital AKH</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.Z. Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dinant Godinne - UCL Namur</name>
      <address>
        <city>Yvoir</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer</name>
      <address>
        <city>Bron</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges-Francois-Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut régional du Cancer Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice - Hopital Pasteur</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugene Marquis</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum - Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Der J.W. Goethe Universitaet</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Muenster, Zentralklinikum</name>
      <address>
        <city>Muenster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetskliniken Regensburg</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen</name>
      <address>
        <city>Tubingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico Carlo Besta</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto IRCCS - Ospedale Busonera</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Regina Elena / Istituti Fisioterapici Ospitalieri</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaarne Gasthuis - Vrije Universiteit Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC Cancer Institute - location Daniel den Hoed</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital - Radiumhospitalet</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic Universitari de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De La Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 De Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois - Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zurich</name>
      <address>
        <city>Zurich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lothian - Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS - St Thomas Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Grade 2 Chordoid meningioma</keyword>
  <keyword>Grade 2 Clear cell meningioma</keyword>
  <keyword>Grade 2 Atypical meningioma</keyword>
  <keyword>Grade 3 Papillary meningioma</keyword>
  <keyword>Grade 3 Rhabdoid meningioma</keyword>
  <keyword>Grade 3 Anaplastic meningioma</keyword>
  <keyword>Grade 3 Malignant meningioma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningioma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trabectedin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234050
org study id: EORTC-1320-BTG
secondary id: 2014-002446-47
nct id: NCT02234050
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS)
time frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first
measure: Progression Free Survival at 6 months (PFS-6), median PFS (mPFS)
time frame: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first
measure: Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration.
time frame: From the date of randomization until disease progression
measure: Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)
time frame: From the date of randomization up to the date of death, up to 12 months
measure: Safety (CTCAE v.4.0)
time frame: From randomization up to 30 days after administration of the last dose of protocol treatment or until the start of a new antitumor therapy, whichever occurs first.
measure: Health-related Quality of life (HRQol)
time frame: Untill six months after randomization
arm group label: Trabectedin
arm group type: Experimental
description: Patient will be treated with trabectedin
arm group label: Local standard of care
arm group type: Other
description: Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.
intervention type: Drug
intervention name: Trabectedin
description: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
arm group label: Trabectedin
other name: Yondelis
intervention type: Other
intervention name: Local standard of care
description: Left to the discretion of the investigator
arm group label: Local standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Preusser
role: Study Chair
affiliation: Medical University Vienna - General Hospital AKH
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country: Austria
country: Belgium
country: France
country: Germany
country: Italy
country: Netherlands
country: Norway
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Meningioma
mesh term: Recurrence
mesh term: Trabectedin