<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/NCT03025893</url>
  </required_header>
  <id_info>
    <org_study_id>2016.221</org_study_id>
    <nct_id>NCT03025893</nct_id>
  </id_info>
  <brief_title>A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme</brief_title>
  <acronym>STELLAR</acronym>
  <official_title>A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme: the STELLAR Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib&#xD;
      versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The&#xD;
      investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule,&#xD;
      will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic&#xD;
      properties, inhibit gliomagenesis by inhibition of multiple kinases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: Multicenter, phase II/III, randomized clinical trial with high-dose sunitinib&#xD;
      versus lomustine (CCNU) in patients with recurrent GBM.&#xD;
&#xD;
      Hypothesis: Sunitinib, when given in a high-dose, intermittent schedule, may exhibit improved&#xD;
      efficacy in patients with recurrent GBM with an acceptable toxicity profile, compared to&#xD;
      lomustine.&#xD;
&#xD;
      Study population: Adult patients with recurrent GBM.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      - To determine the effect of high-dose sunitinib versus lomustine on six-month&#xD;
      progression-free survival (PFS6) in patients with recurrent GBM, using the RANO criteria.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To determine the effect of high-dose sunitinib on overall survival (OS 9, OS 12) in&#xD;
           patients with recurrent GBM.&#xD;
&#xD;
        -  To assess the objective radiological response rate, using the RANO criteria.&#xD;
&#xD;
        -  To assess toxicity, using the Common Toxicity Criteria for Adverse Events (CTCAE)&#xD;
           version 4.0.&#xD;
&#xD;
        -  To assess patient-oriented criteria: steroid use and health-related quality of life&#xD;
           (reported by patients and caregivers/relatives).&#xD;
&#xD;
        -  To explore the potential value of blood markers for molecular diagnostics, disease and&#xD;
           response monitoring.&#xD;
&#xD;
        -  To explore if MGMT promoter methylation status modulates the response to sunitinib.&#xD;
&#xD;
      Treatment: After randomization, 100 patients will be divided equally over two treatment&#xD;
      groups and will receive:&#xD;
&#xD;
        -  Group 1 (experimental arm): Sunitinib, 700 mg administered orally every 2 weeks.&#xD;
&#xD;
        -  Group 2 (control arm): Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.&#xD;
&#xD;
      Disease will be assessed by MRI according to an uniform neuro-oncology protocol every 6 weeks&#xD;
      for the first 6 months and every 12 weeks until documented progression. Safety profile of&#xD;
      both treatment strategies will be assessed separately for each cycle of therapy and every 12&#xD;
      weeks after the end of treatment if adverse effects have not resolved or are newly emerging.&#xD;
      Furthermore, quality of life assessment takes place every 6 weeks using questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 31, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Six-month progression-free survival (PFS-6)</measure>
    <time_frame>From the date of randomization up to the date of first progression or death (any cause) whichever comes first, assessed up to 36 months (End of Study).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From the date of randomization up to the date of death, assessed up to 36 months. If study medication is discontinued for any reason, survival follow-up takes place every 12 weeks, also assessed up to 36 months (End of Study).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective radiological response rate</measure>
    <time_frame>Disease will be assessed by MRI every 6 weeks for the first 6 months and every 12 weeks until documented progression, assessed up to 36 months (End of Study).</time_frame>
    <description>Response will be assessed according to the RANO criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>AEs will be monitored at every visit during study treatment or after discontinuation of study treatment in the case adverse events have not subsided, assessed up to 36 months (End of Study).</time_frame>
    <description>At the end of the study, after 36 months, the number of participants with adverse events that are related to both treatments will be assessed and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life (HRQoL)</measure>
    <time_frame>HRQoL assessments will be performed at baseline and every 6 weeks until documented progression, assessed up to 36 months (End of Study).</time_frame>
    <description>Steroid use will be documented at every treatment cycle as an objective parameter for HRQoL. Furthermore, HRQoL will also be measured via EORTC questionnaires, which will be filled in by the participants every 6 weeks BEFORE their MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood markers (TEP: tumor educated platelets, and miRNA)</measure>
    <time_frame>Blood samples for RNA profiling will be drawn simultaneously with regular blood samples on five specific time points during study treatment and will be assessed after 36 months (End of Study).</time_frame>
    <description>The five specific time points during study treatment are: (1) at baseline; (2) at the first outpatient visit; (3) after two weeks of treatment; (4) at the first response evaluation (first MRI); and (5) at the time of progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGMT promoter methylation status</measure>
    <time_frame>At the end of the study (after 36 months), the treatment outcomes of all patients will be correlated with the MGMT promoter methylation status.</time_frame>
    <description>Previously obtained resection or biopsy material from the first-line treatment of these participants will be requested at the time of inclusion and used to determine the MGMT methylation status. After the End of Study (after 36 months) the MGMT promoter methylation status will be correlated with the response to treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Glioblastoma Multiforme</condition>
  <condition>Glioblastoma, Adult</condition>
  <condition>Glioblastoma</condition>
  <condition>Recurrent Brain Tumor</condition>
  <condition>GBM</condition>
  <arm_group>
    <arm_group_label>Sunitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this experimental arm will receive sunitinib in a high-dose, intermittent schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lomustine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this control arm will receive lomustine, currently used as second-line treatment in the case of recurrence.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sunitinib</intervention_name>
    <description>Sunitinib, 300 mg administered orally in a weekly schedule.</description>
    <arm_group_label>Sunitinib</arm_group_label>
    <other_name>Sutent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lomustine</intervention_name>
    <description>Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.</description>
    <arm_group_label>Lomustine</arm_group_label>
    <other_name>CCNU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed (by the patient or legally acceptable representative) and dated Informed&#xD;
             Consent Form&#xD;
&#xD;
          2. Histologically confirmed de novo or secondary glioblastoma with unequivocal first&#xD;
             progression, at least 3 months off radiotherapy.&#xD;
&#xD;
          3. No more than one line of chemotherapy (concurrent and adjuvant temozolomide based&#xD;
             chemotherapy including in combination with another investigational agent is considered&#xD;
             one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks&#xD;
             prior to randomization.&#xD;
&#xD;
          4. Patients may have undergone surgery for recurrence. If operated, residual and&#xD;
             measurable disease after surgery is not required but surgery must have confirmed the&#xD;
             recurrence.&#xD;
&#xD;
          5. No radiotherapy, stereotactic radiosurgery or brachytherapy as treatment for&#xD;
             recurrence.&#xD;
&#xD;
          6. Patients must have a Karnofsky Performance Score ≥ 70%&#xD;
&#xD;
          7. Patients need to have adequate hematological, renal and hepatic function as assessed&#xD;
             by the following laboratory requirements to be conducted within seven days prior to&#xD;
             start study treatment:&#xD;
&#xD;
               1. Hemoglobin ≥ 7.0 mmol/L&#xD;
&#xD;
               2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L&#xD;
&#xD;
               3. Platelet count ≥ 100 x 109/L&#xD;
&#xD;
               4. ALAT and ASAT ≤ 2.5 x ULN&#xD;
&#xD;
               5. Serum creatinine eGFR ≥ 50 ml/min&#xD;
&#xD;
               6. Albumin ≥ 25 g/L&#xD;
&#xD;
          8. Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of a significant uncontrolled concomitant disease, such as cardiovascular&#xD;
             disease (including stroke, New York Heart Association Class III or IV cardiac disease&#xD;
             or myocardial infarction within 6 months prior to screening, unstable arrhythmia,&#xD;
             clinically significant valvular heart disease and unstable angina); nervous system,&#xD;
             pulmonary (including obstructive pulmonary disease and history of symptomatic&#xD;
             bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious&#xD;
             non-healing wound or fracture.&#xD;
&#xD;
          2. Patients with a prior (&lt; 5 years) or concomitant second malignancy.&#xD;
&#xD;
          3. Prior radiotherapy in the abdomen or in the lungs or in more than 3 vertebrae in the&#xD;
             spine (Less than 3 vertebrae are considered a small radiation field and eligibility&#xD;
             will be decided on an individual basis from the PI).&#xD;
&#xD;
          4. Poorly controlled hypertension despite adequate blood pressure medication. Blood&#xD;
             pressure must be ≤ 160/95 mmHg at the time of screening on a stable antihypertensive&#xD;
             regimen. Blood pressure must be stable on at least 2 separate measurements.&#xD;
&#xD;
          5. Known active bacterial, viral, fungal, mycobacterial, or other infection (including&#xD;
             HIV and atypical mycobacterial disease, but excluding fungal infection of the nail&#xD;
             beds.)&#xD;
&#xD;
          6. Initial MR-scan of the brain showing intratumoral hemorrhage, except for stable&#xD;
             post-operative grade 1 hemorrhage.&#xD;
&#xD;
          7. Known hypersensitivity to sunitinib or to its excipients.&#xD;
&#xD;
          8. Presence of any significant central nervous system or psychiatric disorder(s) that&#xD;
             would interfere with the patient's compliance.&#xD;
&#xD;
          9. Use of full-dose oral or parenteral anticoagulants or thrombolytic agent for&#xD;
             therapeutic (as opposed to prophylactic) purposes.&#xD;
&#xD;
         10. Use of strong hepatic enzyme-inducing antiepileptic drugs, such as carbamazepine,&#xD;
             phenobarbital and phenytoin. If a patient uses one or more of these specific&#xD;
             antiepileptic drugs, they must switch to an antiepileptic drug that does not interact&#xD;
             with cytochrome P450 (CYP450) liver enzymes, such as levetiracetam, prior to the start&#xD;
             of study treatment.&#xD;
&#xD;
         11. Drug or alcohol abuse.&#xD;
&#xD;
         12. Females who are pregnant or breast-feeding.&#xD;
&#xD;
         13. Any evidence of a disease or condition that might affect compliance with the protocol&#xD;
             or interpretation of the study results or render the patient at high risk from&#xD;
             treatment complications.&#xD;
&#xD;
         14. Unwillingness or inability to comply with study and follow-up procedures.&#xD;
&#xD;
         15. Clinically significant history of liver disease, including viral or other hepatitis,&#xD;
             current alcohol abuse, or cirrhosis.&#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>Myra E Van Linde, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Myra E Van Linde, MD</last_name>
    <phone>+31 20 444 4321</phone>
    <email>trialoffice-onc@vumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jorien Janssen, MD</last_name>
    <email>jorien.janssen@radboudumc.nl; trialoffice-onc@vumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorien Janssen, MD</last_name>
      <email>jorien.janssen@radboudumc.nl</email>
    </contact>
    <investigator>
      <last_name>Myra E Van Linde, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jorien Janssen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorien Janssen, MD</last_name>
    </contact>
    <investigator>
      <last_name>Annemiek ME Walenkamp, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jorien Janssen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Radboud UMC</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorien Janssen, MD</last_name>
    </contact>
    <investigator>
      <last_name>Chantal Driessen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jorien Janssen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>M.E. van Linde</investigator_full_name>
    <investigator_title>Medical Oncologist Department of Medical Oncology</investigator_title>
  </responsible_party>
  <keyword>Sunitinib</keyword>
  <keyword>Lomustine</keyword>
  <keyword>High-dose</keyword>
  <keyword>Intermittent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunitinib</mesh_term>
    <mesh_term>Lomustine</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/NCT03025893
org study id: 2016.221
nct id: NCT03025893
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
In this study the investigators will evaluate the effect of high-dose, intermittent sunitinib
      versus treatment with lomustine in patients with recurrent glioblastoma multiforme. The
      investigators hypothesize that sunitinib, when given in a high-dose, intermittent schedule,
      will achieve adequate concentration levels in the tumor and will, besides its anti-angiogenic
      properties, inhibit gliomagenesis by inhibition of multiple kinases.
Study design: Multicenter, phase II/III, randomized clinical trial with high-dose sunitinib
      versus lomustine (CCNU) in patients with recurrent GBM.

      Hypothesis: Sunitinib, when given in a high-dose, intermittent schedule, may exhibit improved
      efficacy in patients with recurrent GBM with an acceptable toxicity profile, compared to
      lomustine.

      Study population: Adult patients with recurrent GBM.

      Primary objective:

      - To determine the effect of high-dose sunitinib versus lomustine on six-month
      progression-free survival (PFS6) in patients with recurrent GBM, using the RANO criteria.

      Secondary objectives:

        -  To determine the effect of high-dose sunitinib on overall survival (OS 9, OS 12) in
           patients with recurrent GBM.

        -  To assess the objective radiological response rate, using the RANO criteria.

        -  To assess toxicity, using the Common Toxicity Criteria for Adverse Events (CTCAE)
           version 4.0.

        -  To assess patient-oriented criteria: steroid use and health-related quality of life
           (reported by patients and caregivers/relatives).

        -  To explore the potential value of blood markers for molecular diagnostics, disease and
           response monitoring.

        -  To explore if MGMT promoter methylation status modulates the response to sunitinib.

      Treatment: After randomization, 100 patients will be divided equally over two treatment
      groups and will receive:

        -  Group 1 (experimental arm): Sunitinib, 700 mg administered orally every 2 weeks.

        -  Group 2 (control arm): Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.

      Disease will be assessed by MRI according to an uniform neuro-oncology protocol every 6 weeks
      for the first 6 months and every 12 weeks until documented progression. Safety profile of
      both treatment strategies will be assessed separately for each cycle of therapy and every 12
      weeks after the end of treatment if adverse effects have not resolved or are newly emerging.
      Furthermore, quality of life assessment takes place every 6 weeks using questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Six-month progression-free survival (PFS-6)
time frame: From the date of randomization up to the date of first progression or death (any cause) whichever comes first, assessed up to 36 months (End of Study).
measure: Overall survival (OS)
time frame: From the date of randomization up to the date of death, assessed up to 36 months. If study medication is discontinued for any reason, survival follow-up takes place every 12 weeks, also assessed up to 36 months (End of Study).
measure: Objective radiological response rate
time frame: Disease will be assessed by MRI every 6 weeks for the first 6 months and every 12 weeks until documented progression, assessed up to 36 months (End of Study).
description: Response will be assessed according to the RANO criteria.
measure: Adverse events (AEs)
time frame: AEs will be monitored at every visit during study treatment or after discontinuation of study treatment in the case adverse events have not subsided, assessed up to 36 months (End of Study).
description: At the end of the study, after 36 months, the number of participants with adverse events that are related to both treatments will be assessed and compared.
measure: Health-related quality of life (HRQoL)
time frame: HRQoL assessments will be performed at baseline and every 6 weeks until documented progression, assessed up to 36 months (End of Study).
description: Steroid use will be documented at every treatment cycle as an objective parameter for HRQoL. Furthermore, HRQoL will also be measured via EORTC questionnaires, which will be filled in by the participants every 6 weeks BEFORE their MRI.
measure: Blood markers (TEP: tumor educated platelets, and miRNA)
time frame: Blood samples for RNA profiling will be drawn simultaneously with regular blood samples on five specific time points during study treatment and will be assessed after 36 months (End of Study).
description: The five specific time points during study treatment are: (1) at baseline; (2) at the first outpatient visit; (3) after two weeks of treatment; (4) at the first response evaluation (first MRI); and (5) at the time of progression.
measure: MGMT promoter methylation status
time frame: At the end of the study (after 36 months), the treatment outcomes of all patients will be correlated with the MGMT promoter methylation status.
description: Previously obtained resection or biopsy material from the first-line treatment of these participants will be requested at the time of inclusion and used to determine the MGMT methylation status. After the End of Study (after 36 months) the MGMT promoter methylation status will be correlated with the response to treatment.
arm group label: Sunitinib
arm group type: Experimental
description: Patients in this experimental arm will receive sunitinib in a high-dose, intermittent schedule.
arm group label: Lomustine
arm group type: Active Comparator
description: Patients in this control arm will receive lomustine, currently used as second-line treatment in the case of recurrence.
intervention type: Drug
intervention name: Sunitinib
description: Sunitinib, 300 mg administered orally in a weekly schedule.
arm group label: Sunitinib
other name: Sutent
intervention type: Drug
intervention name: Lomustine
description: Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.
arm group label: Lomustine
other name: CCNU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Myra E Van Linde, MD
role: Principal Investigator
affiliation: Amsterdam UMC, location VUmc
last name: Myra E Van Linde, MD
phone: +31 20 444 4321
email: trialoffice-onc@vumc.nl
last name: Jorien Janssen, MD
email: jorien.janssen@radboudumc.nl; trialoffice-onc@vumc.nl
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: M.E. van Linde
investigator title: Medical Oncologist Department of Medical Oncology
mesh term: Glioblastoma
mesh term: Brain Neoplasms
mesh term: Recurrence
mesh term: Sunitinib
mesh term: Lomustine