<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/NCT02245997</url>
  </required_header>
  <id_info>
    <org_study_id>14-186</org_study_id>
    <nct_id>NCT02245997</nct_id>
  </id_info>
  <brief_title>Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma</brief_title>
  <official_title>Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to give 12T a smaller dose of radiation in order to decrease&#xD;
      these late side effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>N/A</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>assess local control rates treatment response</measure>
    <time_frame>3 yeas</time_frame>
    <description>will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>event-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>will be performed for each patient using clinical data and imaging. Events are defined as failure (loco-regional and/or distant), treatment-related malignancy, or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of toxicity</measure>
    <time_frame>3 years</time_frame>
    <description>will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Neuroblastoma</condition>
  <arm_group>
    <arm_group_label>patients with high-risk neuroblastoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 6 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External beam radiotherapy</intervention_name>
    <arm_group_label>patients with high-risk neuroblastoma</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>proton beam RT</intervention_name>
    <arm_group_label>patients with high-risk neuroblastoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a diagnosis of neuroblastoma (International Classification of&#xD;
             Disease for Oncology [ICD-O] morphology 9500/3) confirmed by MSKCC pathologic review&#xD;
&#xD;
          -  Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification&#xD;
             Schema&#xD;
&#xD;
             o Patients with International agreement on staging (INSS) stage 4 are eligible with&#xD;
             the following:&#xD;
&#xD;
          -  MYCN amplification, regardless of age or additional biologic features&#xD;
&#xD;
          -  Age &gt;18 months, regardless of biologic features OR&#xD;
&#xD;
          -  Age 1-18 months, with any of the 3 following unfavorable biologic OR features: MYCN&#xD;
             amplification, unfavorable pathology, and/or DNA index = 1&#xD;
&#xD;
             o Patients with INSS stage 3 are eligible with the following:&#xD;
&#xD;
          -  MYCN amplification, regardless of age or additional biologic features OR&#xD;
&#xD;
          -  Age &gt; 18 months with unfavorable pathology, regardless of MYCN status&#xD;
&#xD;
             o Patients with INSS stage 2a or 2b are eligible with the following:&#xD;
&#xD;
          -  MYCN amplification, regardless of age or additional biologic features&#xD;
&#xD;
             o Patients with INSS stage 4s are eligible with the following:&#xD;
&#xD;
          -  MYCN amplification, regardless of additional biologic features Patients must have&#xD;
             undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on&#xD;
             trial.&#xD;
&#xD;
          -  Age at time of enrollment of ≥1 month and ≤18 years&#xD;
&#xD;
          -  Female patients of childbearing potential must have a negative pregnancy test within&#xD;
             14 days of radiation start.&#xD;
&#xD;
          -  Female patients who are lactating must agree to stop breast-feeding.&#xD;
&#xD;
          -  Sexually active patients of childbearing potential must agree to use effective&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with gross residual tumor after surgical resection&#xD;
&#xD;
          -  Patients who have received prior radiotherapy at or adjacent to the primary tumor bed&#xD;
&#xD;
          -  Patients with any concurrent medical or psychiatric condition or disease which, in the&#xD;
             investigator's judgment, would make them inappropriate candidates for entry into this&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Wolden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suzanne Wolden, MD</last_name>
    <phone>212-639-5148</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brian Kushner, MD</last_name>
    <phone>212-639-6793</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzanne Wolden, MD</last_name>
      <phone>212-639-5148</phone>
    </contact>
    <contact_backup>
      <last_name>Leonard Wexler, MD</last_name>
      <phone>212-639-7990</phone>
    </contact_backup>
    <investigator>
      <last_name>Suzanne Wolden, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reduced-dose Radiotherapy</keyword>
  <keyword>14-186</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroblastoma</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/NCT02245997
org study id: 14-186
nct id: NCT02245997
lead sponsor: 
The purpose of this study is to give 12T a smaller dose of radiation in order to decrease
      these late side effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: assess local control rates treatment response
time frame: 3 yeas
description: will be assessed via imaging (CT+/- MRI and MIBG) and clinical evidence at the primary site post completion of treatment. The baseline scan will be the pre-irradiation CT scan. Local failure is defined as a relapse in the primary tumor bed or adjacent lymph nodes.
measure: event-free survival
time frame: 3 years
description: will be performed for each patient using clinical data and imaging. Events are defined as failure (loco-regional and/or distant), treatment-related malignancy, or death.
measure: Assessment of toxicity
time frame: 3 years
description: will occur at the pre-specified follow-up time-points using the CTCAE version 4.0 grading system.
arm group label: patients with high-risk neuroblastoma
arm group type: Experimental
description: Patients undergo external beam radiation therapy using IMRT or proton beam RT twice daily for 5-6 weekdays (10-12 treatments). Patients will be evaluated by physical exams, CT scan or MRI of the primary site, and MIBG at, 6, 12, 18 and 24 months (+/- 6 weeks).
intervention type: Radiation
intervention name: External beam radiotherapy
arm group label: patients with high-risk neuroblastoma
other name: IMRT
intervention type: Radiation
intervention name: proton beam RT
arm group label: patients with high-risk neuroblastoma
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Years
healthy volunteers: No
last name: Suzanne Wolden, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Suzanne Wolden, MD
phone: 212-639-5148
last name: Brian Kushner, MD
phone: 212-639-6793
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Neuroblastoma