<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/NCT03028337</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0728</org_study_id>
    <secondary_id>NCI-2017-00606</secondary_id>
    <nct_id>NCT03028337</nct_id>
  </id_info>
  <brief_title>Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases</brief_title>
  <official_title>Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn whether delivering spine radiosurgery in&#xD;
      a single large dose is better than delivering spine radiosurgery over 3 smaller doses.&#xD;
&#xD;
      Researchers also want to learn about the effects of a single dose on participant's symptoms,&#xD;
      pain, and quality-of-life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Groups:&#xD;
&#xD;
      Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This&#xD;
      is done because no one knows if one study group is better, the same, or worse than the other&#xD;
      group.&#xD;
&#xD;
        -  If participant is in Group 1, they will receive spine radiosurgery in a single large&#xD;
           dose.&#xD;
&#xD;
        -  If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses,&#xD;
           which is standard.&#xD;
&#xD;
      Length of Study Participation:&#xD;
&#xD;
      Participant may continue taking part in the study as the doctor thinks it is in their best&#xD;
      interest. Participant will no longer be able to take part if the disease gets worse, if&#xD;
      intolerable side effects occur, or if they are unable to follow study directions.&#xD;
&#xD;
      Participation on the study will be over after participant's last follow-up visit.&#xD;
&#xD;
      Radiosurgery:&#xD;
&#xD;
      Participant will have spine radiosurgery in either 1 or 3 treatments as described above.&#xD;
&#xD;
      Participant will sign a separate consent for the surgery that explains the procedure and the&#xD;
      risks.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      After surgery, at Months 3,6,9,12,18, and 24 and then every 6 months after that:&#xD;
&#xD;
        -  Participant will have a physical exam, including a neurological exam (tests to check the&#xD;
           functioning of their nerves, including tests of their strength and sensation.&#xD;
&#xD;
        -  Participant will complete the same questionnaires they completed at the beginning of the&#xD;
           study.&#xD;
&#xD;
        -  Participant will have an MRI.&#xD;
&#xD;
      This is an investigational study. Delivering spine radiosurgery in a single large dose rather&#xD;
      than over three smaller doses is considered investigational.&#xD;
&#xD;
      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Anticipated">May 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2024</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases</measure>
    <time_frame>12 months</time_frame>
    <description>Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases</measure>
    <time_frame>2 years</time_frame>
    <description>Pain relief assessed by items on the Brief Pain Inventory (BPI) that measure severity, location, and degree of relief due to therapy by use of narcotic and non-narcotic pain medications and steroids. Patients experiencing a decrease of 2 points in the worst pain score for 2 consecutive assessment visits considered to have &quot;partial pain relief&quot;. Complete pain relief defined as an average pain score of 0 for 2 consecutive assessment visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System</condition>
  <arm_group>
    <arm_group_label>Spine Radiosurgery - 1 Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive spine radiosurgery in a single large dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spine Radiosurgery - 3 Doses</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive spine radiosurgery over 3 smaller doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Spine Radiosurgery</intervention_name>
    <description>Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively.&#xD;
Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction).</description>
    <arm_group_label>Spine Radiosurgery - 1 Dose</arm_group_label>
    <arm_group_label>Spine Radiosurgery - 3 Doses</arm_group_label>
    <other_name>Radiotherapy</other_name>
    <other_name>XRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires.&#xD;
Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up.</description>
    <arm_group_label>Spine Radiosurgery - 1 Dose</arm_group_label>
    <arm_group_label>Spine Radiosurgery - 3 Doses</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients must have histologic proof of solid tumor malignancy and radiographic&#xD;
             evidence of spine metastasis&#xD;
&#xD;
          2. Age &gt;/=18 years&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status &lt;/=2 (Karnofsky &gt;/=60%)&#xD;
&#xD;
          4. Life expectancy of greater than 6 months&#xD;
&#xD;
          5. All patients must be able to lie supine&#xD;
&#xD;
          6. All patients must have no more than 3 contiguous vertebral body levels treated at a&#xD;
             single site, and no more than 3 discontiguous vertebral body levels treated&#xD;
&#xD;
          7. All patients must have radiographic evidence of progression at a spinal site&#xD;
             previously irradiated greater than 6 months prior to randomization. This includes&#xD;
             indirect radiation exposure to spinal site.&#xD;
&#xD;
          8. All patients must have received prior conventional external-beam radiation therapy&#xD;
             (cEBRT) to the site of interest to no more than a critical neural tissue dose&#xD;
             equivalent dose (EQD)2/2 of 42 Gy in a single session or 50 Gy cumulative over&#xD;
             multiple sessions and cauda equina dose EQD2/2 of 50 Gy in a single session or 60 Gy&#xD;
             cumulative over multiple session. EQD2/2 is calculated as follows: EQD2/2=&#xD;
             biologically effective dose (BED)/(1+d/alpha beta)) where BED=nd(1+d/(alpha beta)) and&#xD;
             n=number of fractions, d=dose per fraction and alpha beta ratio of 2.&#xD;
&#xD;
          9. All patients must have a vertebral body site to be treated located from T1 to L5&#xD;
&#xD;
         10. Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for&#xD;
             the duration of study participation. Should a woman become pregnant or suspect she is&#xD;
             pregnant while she or her partner is participating in this study, she should inform&#xD;
             her treating physician immediately.&#xD;
&#xD;
         11. All patients must sign informed consent verifying that they are aware of the&#xD;
             investigational nature of this study in keeping with the rules and policies of MD&#xD;
             Anderson Cancer Center. The only acceptable consent is the one approved by MD Anderson&#xD;
             IRB.&#xD;
&#xD;
         12. Patients undergoing prior surgery or laser interstitial thermotherapy are allowed&#xD;
&#xD;
         13. Both men and women of all races and ethnic groups are eligible for this trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable to undergo magnetic resonance imaging (MRI) of the spine&#xD;
&#xD;
          2. Prior radiation at the site of interest within 6 months&#xD;
&#xD;
          3. Prior history of radiation at the site of interest resulting in a critical neural&#xD;
             tissue dose of EQD2/2 of &gt;42 Gy in a single session&#xD;
&#xD;
          4. Patients unable to lie flat comfortably for 2 hours&#xD;
&#xD;
          5. Pregnancy status will be obtained at time of consent as is routine for all radiation&#xD;
             patients. Pregnant women are excluded from this study because radiation has the&#xD;
             potential for teratogenic or abortifacient effects&#xD;
&#xD;
          6. Patients with a histology of lymphoma and myeloma histologies&#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>Amol J. Ghia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amol J. Ghia, MD</last_name>
    <phone>713-563-2300</phone>
    <email>CR_Study_Registration@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Research Operations</last_name>
      <email>CR_Study_Registration@mdanderson.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malignant neoplasms of eye brain and other parts of central nervous system</keyword>
  <keyword>Solid tumor malignancy</keyword>
  <keyword>Radiographic evidence of spine metastasis</keyword>
  <keyword>Spine radiosurgery</keyword>
  <keyword>Radiation therapy</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>XRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Eye Neoplasms</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/NCT03028337
org study id: 2016-0728
secondary id: NCI-2017-00606
nct id: NCT03028337
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this clinical research study is to learn whether delivering spine radiosurgery in
      a single large dose is better than delivering spine radiosurgery over 3 smaller doses.

      Researchers also want to learn about the effects of a single dose on participant's symptoms,
      pain, and quality-of-life.
Study Groups:

      Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This
      is done because no one knows if one study group is better, the same, or worse than the other
      group.

        -  If participant is in Group 1, they will receive spine radiosurgery in a single large
           dose.

        -  If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses,
           which is standard.

      Length of Study Participation:

      Participant may continue taking part in the study as the doctor thinks it is in their best
      interest. Participant will no longer be able to take part if the disease gets worse, if
      intolerable side effects occur, or if they are unable to follow study directions.

      Participation on the study will be over after participant's last follow-up visit.

      Radiosurgery:

      Participant will have spine radiosurgery in either 1 or 3 treatments as described above.

      Participant will sign a separate consent for the surgery that explains the procedure and the
      risks.

      Study Visits:

      After surgery, at Months 3,6,9,12,18, and 24 and then every 6 months after that:

        -  Participant will have a physical exam, including a neurological exam (tests to check the
           functioning of their nerves, including tests of their strength and sensation.

        -  Participant will complete the same questionnaires they completed at the beginning of the
           study.

        -  Participant will have an MRI.

      This is an investigational study. Delivering spine radiosurgery in a single large dose rather
      than over three smaller doses is considered investigational.

      Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
time frame: 12 months
description: Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.
measure: Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
time frame: 2 years
description: Pain relief assessed by items on the Brief Pain Inventory (BPI) that measure severity, location, and degree of relief due to therapy by use of narcotic and non-narcotic pain medications and steroids. Patients experiencing a decrease of 2 points in the worst pain score for 2 consecutive assessment visits considered to have "partial pain relief". Complete pain relief defined as an average pain score of 0 for 2 consecutive assessment visits.
arm group label: Spine Radiosurgery - 1 Dose
arm group type: Experimental
description: Participants receive spine radiosurgery in a single large dose.
arm group label: Spine Radiosurgery - 3 Doses
arm group type: Active Comparator
description: Participants receive spine radiosurgery over 3 smaller doses.
intervention type: Radiation
intervention name: Spine Radiosurgery
description: Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively.
Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction).
arm group label: Spine Radiosurgery - 1 Dose
arm group label: Spine Radiosurgery - 3 Doses
other name: Radiotherapy
other name: XRT
intervention type: Behavioral
intervention name: Questionnaires
description: Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires.
Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up.
arm group label: Spine Radiosurgery - 1 Dose
arm group label: Spine Radiosurgery - 3 Doses
other name: Surveys
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amol J. Ghia, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Amol J. Ghia, MD
phone: 713-563-2300
email: CR_Study_Registration@mdanderson.org
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Eye Neoplasms