<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/NCT02972229</url>
  </required_header>
  <id_info>
    <org_study_id>WuhanUH201610</org_study_id>
    <nct_id>NCT02972229</nct_id>
  </id_info>
  <brief_title>Whole Versus Partial Vertebral Body IMRT for Spinal Metastases</brief_title>
  <official_title>Whole Versus Partial Vertebral Body IMRT for Spinal Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy&#xD;
      for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic&#xD;
      spinal tumors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, randomized, single center, controlled explorative study in the&#xD;
      parallel-group design to evaluate the difference in clinical outcomes for patients with&#xD;
      metastatic spine disease treated with a whole versus partial vertebral body contouring&#xD;
      approach. Thereby two different techniques were evaluated: whole vertebral body (WB) group&#xD;
      with 10 x 3Gy or partial vertebral body (PB) group with 10x (3-5)Gy. Prior to their enrolment&#xD;
      into the study, the patients will undergo a staging of the vertebral column in connection&#xD;
      with their radiation-planning computed tomography (CT) and MRI to measure the myelon&#xD;
      dimension. After the baseline results have been recorded, the patients will be randomized&#xD;
      into one of the two groups: PB group RT 10x (3-5) Gy (n = 30) or WB group RT 10 x 3 Gy (n =&#xD;
      30). The target parameters will be measured and recorded at baseline, at 1 to 2 weeks; and at&#xD;
      months 2 to 3, 4 to 6 and 7 to 12 after treatment.&#xD;
&#xD;
      The primary endpoint was the time to pain relief. Secondary endpoints were quality of life&#xD;
      (QoL), fatigue, pain, overall survival, bone survival, local control, pathological fracture,&#xD;
      pain-free internal and neurological deficit. The baseline examination shall be carried out on&#xD;
      the first day of radiotherapy prior to the start of therapy and is scheduled to comprise the&#xD;
      comprehensive recording of the sociodemographic data, the recording of the current pain&#xD;
      situation, the quality of life, and the current degree of fatigue. The follow-up examinations&#xD;
      shall take place at each follow up visit , measuring those parameters recorded at the&#xD;
      baseline examination. The further follow-up examinations shall correspond to those carried&#xD;
      out as standard after-care investigations.&#xD;
&#xD;
      The secondary endpoints such as fatigue and quality of life shall be recorded using validated&#xD;
      questionnaires (EORTC QLQ FA13 and EORTC QLQ BM22. All patients will also be asked to record&#xD;
      their pain history using a pain diary (documentation of medication daily during treatment,&#xD;
      once weekly after the end of treatment, VAS pain scale). Furthermore, the local control was&#xD;
      assessed by means of CT images taken prior to, three and six months after RT. The pain&#xD;
      response was documented on the VAS (range 0-10). Complete response (CR) was defined as VAS =&#xD;
      0 after three and six months, partial response (PR) as an improvement by at least two score&#xD;
      points after three and six months. Overall survival (OS) was defined as time from initial&#xD;
      diagnosis until death, bone survival as time from initial diagnosis of spinal bone metastasis&#xD;
      until death.&#xD;
&#xD;
      In each case, the treatment plan was designed based on tumor geometry, proximity to the&#xD;
      spinal cord, and location. The planning tumor volume (PTV) was defined as equal to gross&#xD;
      tumor volume (GTV). The spinal cord, cauda equina, nerve roots, and bowel were contoured as&#xD;
      organs at risk (OARs) and critical structures. An inverse treatment planning method along&#xD;
      with a linear optimization algorithm were employed. The target volume was designated to&#xD;
      include either the GTV and the entire vertebral body (WB group) or only the GTV (PB group) at&#xD;
      each spinal level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the time to pain relief</measure>
    <time_frame>3 months after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life measured on an EORTC BM22 questionnaire</measure>
    <time_frame>3 and 6 months after therapy completed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local control</measure>
    <time_frame>3 months after therapy completed</time_frame>
    <description>local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>partial body group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10x(3-5) Gy IMRT on partial vertebral body</description>
  </arm_group>
  <arm_group>
    <arm_group_label>whole body group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10x3 Gy IMRT on whole vertebral body</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>10x(3-5) Gy IMRT</intervention_name>
    <description>10x(3-5) Gy IMRT on partial vertebral body for spinal metastases</description>
    <arm_group_label>partial body group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>10x3 Gy IMRT</intervention_name>
    <description>10x3 Gy IMRT on whole vertebral body for spinal metastases</description>
    <arm_group_label>whole body group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a histologically confirmed tumor diagnosis, with secondary -diagnosed&#xD;
             solitary/multiple spinal bone metastases&#xD;
&#xD;
          -  Indication for RT of the spinal bone metastases&#xD;
&#xD;
          -  Maximal two irradiated vertebral-bodies per region&#xD;
&#xD;
          -  Maximal two different vertebral regions&#xD;
&#xD;
          -  Age: between 18 and 80 years&#xD;
&#xD;
          -  Karnofsky index (10) ≥ 70&#xD;
&#xD;
          -  Signed Declaration of Informed Consent&#xD;
&#xD;
          -  Tumor distance &gt; 3 mm to myelon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple myeloma or lymphoma&#xD;
&#xD;
          -  Significant neurological or psychiatric disorders, including dementia and epileptic&#xD;
             seizures&#xD;
&#xD;
          -  Earlier RT at the current irradiated site&#xD;
&#xD;
          -  Other severe disorders that in the judgement of the study director may prevent the&#xD;
             patient's participation in the study&#xD;
&#xD;
          -  Lacking or diminished legal capacity&#xD;
&#xD;
          -  Any medical of psychological condition that the study director considers a preventive&#xD;
             factor for the patient's ability to complete the study or to adequately&#xD;
&#xD;
          -  understand the scope of the study and to give his/her consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Zhenwei Zou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02972229
org study id: WuhanUH201610
nct id: NCT02972229
lead sponsor: 
has dmc: Yes
To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy
      for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic
      spinal tumors
This study is a prospective, randomized, single center, controlled explorative study in the
      parallel-group design to evaluate the difference in clinical outcomes for patients with
      metastatic spine disease treated with a whole versus partial vertebral body contouring
      approach. Thereby two different techniques were evaluated: whole vertebral body (WB) group
      with 10 x 3Gy or partial vertebral body (PB) group with 10x (3-5)Gy. Prior to their enrolment
      into the study, the patients will undergo a staging of the vertebral column in connection
      with their radiation-planning computed tomography (CT) and MRI to measure the myelon
      dimension. After the baseline results have been recorded, the patients will be randomized
      into one of the two groups: PB group RT 10x (3-5) Gy (n = 30) or WB group RT 10 x 3 Gy (n =
      30). The target parameters will be measured and recorded at baseline, at 1 to 2 weeks; and at
      months 2 to 3, 4 to 6 and 7 to 12 after treatment.

      The primary endpoint was the time to pain relief. Secondary endpoints were quality of life
      (QoL), fatigue, pain, overall survival, bone survival, local control, pathological fracture,
      pain-free internal and neurological deficit. The baseline examination shall be carried out on
      the first day of radiotherapy prior to the start of therapy and is scheduled to comprise the
      comprehensive recording of the sociodemographic data, the recording of the current pain
      situation, the quality of life, and the current degree of fatigue. The follow-up examinations
      shall take place at each follow up visit , measuring those parameters recorded at the
      baseline examination. The further follow-up examinations shall correspond to those carried
      out as standard after-care investigations.

      The secondary endpoints such as fatigue and quality of life shall be recorded using validated
      questionnaires (EORTC QLQ FA13 and EORTC QLQ BM22. All patients will also be asked to record
      their pain history using a pain diary (documentation of medication daily during treatment,
      once weekly after the end of treatment, VAS pain scale). Furthermore, the local control was
      assessed by means of CT images taken prior to, three and six months after RT. The pain
      response was documented on the VAS (range 0-10). Complete response (CR) was defined as VAS =
      0 after three and six months, partial response (PR) as an improvement by at least two score
      points after three and six months. Overall survival (OS) was defined as time from initial
      diagnosis until death, bone survival as time from initial diagnosis of spinal bone metastasis
      until death.

      In each case, the treatment plan was designed based on tumor geometry, proximity to the
      spinal cord, and location. The planning tumor volume (PTV) was defined as equal to gross
      tumor volume (GTV). The spinal cord, cauda equina, nerve roots, and bowel were contoured as
      organs at risk (OARs) and critical structures. An inverse treatment planning method along
      with a linear optimization algorithm were employed. The target volume was designated to
      include either the GTV and the entire vertebral body (WB group) or only the GTV (PB group) at
      each spinal level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: the time to pain relief
time frame: 3 months after treatment
measure: quality of life measured on an EORTC BM22 questionnaire
time frame: 3 and 6 months after therapy completed
measure: Overall survival
time frame: 1 year
measure: local control
time frame: 3 months after therapy completed
description: local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
arm group label: partial body group
arm group type: Experimental
description: 10x(3-5) Gy IMRT on partial vertebral body
arm group label: whole body group
arm group type: Active Comparator
description: 10x3 Gy IMRT on whole vertebral body
intervention type: Radiation
intervention name: 10x(3-5) Gy IMRT
description: 10x(3-5) Gy IMRT on partial vertebral body for spinal metastases
arm group label: partial body group
intervention type: Radiation
intervention name: 10x3 Gy IMRT
description: 10x3 Gy IMRT on whole vertebral body for spinal metastases
arm group label: whole body group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Zhenwei Zou
investigator title: Principal Investigator
mesh term: Neoplasm Metastasis
sharing ipd: No