<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/NCT03251027</url>
  </required_header>
  <id_info>
    <org_study_id>17D.074</org_study_id>
    <nct_id>NCT03251027</nct_id>
  </id_info>
  <brief_title>Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma</brief_title>
  <official_title>Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well intensity-modulated stereotactic radiation therapy works&#xD;
      in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized&#xD;
      radiation therapy that delivers a single, high dose of radiation directly to the tumor and&#xD;
      may cause less damage to normal tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the&#xD;
      incidence of wound infection (requiring oral/intravenous [IV] antibiotics or surgery), or&#xD;
      wound dehiscence.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable&#xD;
      cranial defects due to scalp thinning.&#xD;
&#xD;
      II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.&#xD;
&#xD;
      III. To determine the effect on quality of life (QoL) using European Quality of Life Five&#xD;
      Dimension Five Level Scale Questionnaire (EQ-5D-5L).&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in&#xD;
      patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in&#xD;
      the coronal plane in T-1W magnetic resonance (MR) images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of wound infection or wound dehiscence</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of titanium implants</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will the impact of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. Rates of titanium implant discomfort will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hair loss</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will assess the impact of IM-SRT on the incidence of hair loss. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of recovery rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will assess the impact of IM-SRT on the incidence of recovery rate. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will assess the impact on quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be modeled using mixed effects linear regression. Within-cohort changes will be estimated using linear contrasts of model parameters.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Scalp thickness</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Will assess the IM-SRT on scalp thickness as determined by magnetic resonance imaging evaluations of scalp thickness in the coronal plane before conformal radiation therapy (XRT), at 9 months, and 18 months after XRT in the study group compared to time-matched historical controls of patients. Mixed effects linear regression will be used to jointly model scalp thickness measurements at pre-treatment, 9 months, and 18 months. Potential confounding factors (chemotherapy, smoking history, diabetes) will also be included in the model. The residual variance covariance matrix will be assumed to have a compound-symmetric structure to account for the correlation among repeated measurements. Linear contrasts will be used to compare the change from pre-treatment to 9 months between IM-SRT and conformal therapy patients and to compare the change from pre treatment to 18 months between IM-SRT and conformal therapy patients.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Glioblastoma</condition>
  <condition>WHO Grade II Glioma</condition>
  <condition>WHO Grade III Glioma</condition>
  <arm_group>
    <arm_group_label>Treatment (IM-SRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-Modulated Radiation Therapy</intervention_name>
    <description>Undergo IM-SRT</description>
    <arm_group_label>Treatment (IM-SRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (IM-SRT)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
    <other_name>Quality-of-Life Assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed low or high grade glioma (grade II-IV)&#xD;
&#xD;
          -  Karnofsky performance status (KPS) &gt;= 60&#xD;
&#xD;
          -  Patients must have recovered from the effects of surgery; there must be a minimum of&#xD;
             21 days from the day of surgery to the day of protocol treatment&#xD;
&#xD;
          -  Estimated survival &gt;= 3 months&#xD;
&#xD;
          -  Labs considered acceptable per standard of care&#xD;
&#xD;
          -  Patient must sign a study specific informed consent form&#xD;
&#xD;
          -  Radiation treatment must begin &gt;= 3 weeks and =&lt; 8 weeks after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of scalp radiation or intolerance to standard course of radiation&#xD;
             treatment&#xD;
&#xD;
          -  Co-morbidities that would influence wound healing including diabetes (insulin&#xD;
             dependent) or smoking (current ongoing use)&#xD;
&#xD;
          -  Pregnancy or women of childbearing potential and men who are sexually active and not&#xD;
             willing/able to use medically acceptable forms of contraception&#xD;
&#xD;
          -  Karnofsky performance status (KPS) &lt; 60&#xD;
&#xD;
          -  Patient can't have magnetic resonance imaging (MRI) scan&#xD;
&#xD;
          -  Active collagen vascular disease&#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>Wenyin Shi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wenyin Shi, MD</last_name>
    <phone>(215) 955-6702</phone>
    <email>wenyin.shi@jefferson.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sidney Kimmel Cancer Center at Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Andrews, MD</last_name>
      <phone>215-955-7000</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
  </condition_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/NCT03251027
org study id: 17D.074
nct id: NCT03251027
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This phase II trial studies how well intensity-modulated stereotactic radiation therapy works
      in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized
      radiation therapy that delivers a single, high dose of radiation directly to the tumor and
      may cause less damage to normal tissue.
PRIMARY OBJECTIVES:

      I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the
      incidence of wound infection (requiring oral/intravenous [IV] antibiotics or surgery), or
      wound dehiscence.

      SECONDARY OBJECTIVES:

      I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable
      cranial defects due to scalp thinning.

      II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.

      III. To determine the effect on quality of life (QoL) using European Quality of Life Five
      Dimension Five Level Scale Questionnaire (EQ-5D-5L).

      TERTIARY OBJECTIVES:

      I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in
      patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in
      the coronal plane in T-1W magnetic resonance (MR) images.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of wound infection or wound dehiscence
time frame: Up to 2 years
description: Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.
measure: Incidence of titanium implants
time frame: Up to 2 years
description: Will the impact of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. Rates of titanium implant discomfort will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.
measure: Incidence of hair loss
time frame: Up to 2 years
description: Will assess the impact of IM-SRT on the incidence of hair loss. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.
measure: Incidence of recovery rate
time frame: Up to 2 years
description: Will assess the impact of IM-SRT on the incidence of recovery rate. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.
measure: Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire
time frame: Up to 2 years
description: Will assess the impact on quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be modeled using mixed effects linear regression. Within-cohort changes will be estimated using linear contrasts of model parameters.
measure: Scalp thickness
time frame: Up to 18 months
description: Will assess the IM-SRT on scalp thickness as determined by magnetic resonance imaging evaluations of scalp thickness in the coronal plane before conformal radiation therapy (XRT), at 9 months, and 18 months after XRT in the study group compared to time-matched historical controls of patients. Mixed effects linear regression will be used to jointly model scalp thickness measurements at pre-treatment, 9 months, and 18 months. Potential confounding factors (chemotherapy, smoking history, diabetes) will also be included in the model. The residual variance covariance matrix will be assumed to have a compound-symmetric structure to account for the correlation among repeated measurements. Linear contrasts will be used to compare the change from pre-treatment to 9 months between IM-SRT and conformal therapy patients and to compare the change from pre treatment to 18 months between IM-SRT and conformal therapy patients.
arm group label: Treatment (IM-SRT)
arm group type: Experimental
description: Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.
intervention type: Radiation
intervention name: Intensity-Modulated Radiation Therapy
description: Undergo IM-SRT
arm group label: Treatment (IM-SRT)
intervention type: Other
intervention name: Quality-of-Life
description: Ancillary studies
arm group label: Treatment (IM-SRT)
other name: Quality of Life Assessment
other name: Quality-of-Life Assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wenyin Shi, MD
role: Principal Investigator
affiliation: Thomas Jefferson University
last name: Wenyin Shi, MD
phone: (215) 955-6702
email: wenyin.shi@jefferson.edu
facility: 
status: Recruiting
contact: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Glioma