<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/NCT03797755</url>
  </required_header>
  <id_info>
    <org_study_id>NTWC_Onc_2019</org_study_id>
    <nct_id>NCT03797755</nct_id>
  </id_info>
  <brief_title>Prognosis of Patient Evaluated for Palliative Radiotherapy</brief_title>
  <acronym>PROPER</acronym>
  <official_title>Prospective Observational Study of the Prognosis of Patients Having Palliative Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tuen Mun Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tuen Mun Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Many patients with incurable cancer will receive palliative oncological treatment before&#xD;
      their death, and radiotherapy (RT) is an important element of this. The aim of palliative RT&#xD;
      is to alleviate symptoms and improve quality of life. An accurate and practical survival&#xD;
      prediction model for metastatic cancer patient receiving palliative RT can assist the&#xD;
      decision making (ranging from best supportive treatment alone for expected short survival, to&#xD;
      dose escalation for potential better disease control).&#xD;
&#xD;
      The available survival prediction models (such Survival Prediction Score using Number of Risk&#xD;
      Factors by Chow et al and TEACHH model) have been developed in the Western world. We&#xD;
      therefore perform a prospective observational study 1) to assess the overall survival of&#xD;
      patients evaluated for palliative RT at a tertiary hospital in Hong Kong, and 2) to validate&#xD;
      the prognostic score systems in our population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 year</time_frame>
    <description>Overall Survival in the studied population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival in Each Indication of Palliative Radiotherapy</measure>
    <time_frame>3, 6, 9, 12 months</time_frame>
    <description>Indications of Palliative Radiotherapy:&#xD;
The indication will be as follow:&#xD;
spinal cord compression brain metastases tumor bleeding tumoral mass Cancer pain Superior Vena Cava Syndrome/ Airway compression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival by Survival Prediction Model (NRF)</measure>
    <time_frame>3, 6, 9, 12 months</time_frame>
    <description>Overall Survival by Survival Prediction Score using Number of Risk Factors (NRF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival by Survival Prediction Model (TEACHH)</measure>
    <time_frame>3, 6, 9, 12 months</time_frame>
    <description>Overall Survival by Survival Prediction Score using TEACHH Model</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Cancer</condition>
  <condition>Radiotherapy</condition>
  <arm_group>
    <arm_group_label>Palliative Cancer Patients</arm_group_label>
    <description>Stage IV cancer patients evaluated for palliative radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>palliative radiotherapy</intervention_name>
    <description>Radiotherapy for palliating symptoms in stage IV cancer patients</description>
    <arm_group_label>Palliative Cancer Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stage IV cancer patients evaluated for palliative radiotherapy in Tuen Mun Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients with stage IV cancer who are referred for palliative RT in Tuen Mun&#xD;
             Hospital, including both inpatients and outpatients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received palliative RT before (i.e. not the first course palliative&#xD;
             RT), have non-metastatic disease, are misclassified as palliative patients.&#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>Shing Fung Lee, MBBS (HK), FRCR (UK)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Oncology, New Territory West Cluster, Hospital Authority, Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shing Fung Lee, MBBS (HK), FRCR (UK)</last_name>
    <phone>852 2468 5087</phone>
    <email>leesfm@ha.org.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Clinical Oncology, Tuen Mun Hospital, Tuen Mun</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shing Fung Lee, MBBS (HK), FRCR (UK)</last_name>
      <phone>852 2468 5087</phone>
      <email>leesfm@ha.org.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Chow E, Harth T, Hruby G, Finkelstein J, Wu J, Danjoux C. How accurate are physicians' clinical predictions of survival and the available prognostic tools in estimating survival times in terminally ill cancer patients? A systematic review. Clin Oncol (R Coll Radiol). 2001;13(3):209-18. doi: 10.1053/clon.2001.9256.</citation>
    <PMID>11527298</PMID>
  </reference>
  <reference>
    <citation>Christakis NA, Lamont EB. Extent and determinants of error in doctors' prognoses in terminally ill patients: prospective cohort study. BMJ. 2000 Feb 19;320(7233):469-72. doi: 10.1136/bmj.320.7233.469.</citation>
    <PMID>10678857</PMID>
  </reference>
  <reference>
    <citation>Gripp S, Mjartan S, Boelke E, Willers R. Palliative radiotherapy tailored to life expectancy in end-stage cancer patients: reality or myth? Cancer. 2010 Jul 1;116(13):3251-6. doi: 10.1002/cncr.25112.</citation>
    <PMID>20564632</PMID>
  </reference>
  <reference>
    <citation>Chow E, Abdolell M, Panzarella T, Harris K, Bezjak A, Warde P, Tannock I. Predictive model for survival in patients with advanced cancer. J Clin Oncol. 2008 Dec 20;26(36):5863-9. doi: 10.1200/JCO.2008.17.1363. Epub 2008 Nov 17.</citation>
    <PMID>19018082</PMID>
  </reference>
  <reference>
    <citation>Peppercorn JM, Smith TJ, Helft PR, Debono DJ, Berry SR, Wollins DS, Hayes DM, Von Roenn JH, Schnipper LE; American Society of Clinical Oncology. American society of clinical oncology statement: toward individualized care for patients with advanced cancer. J Clin Oncol. 2011 Feb 20;29(6):755-60. doi: 10.1200/JCO.2010.33.1744. Epub 2011 Jan 24.</citation>
    <PMID>21263086</PMID>
  </reference>
  <reference>
    <citation>Chow E, James JL, Hartsell W, Scarantino CW, Ivker R, Roach M III, Suh JH, Demas W, Konski A, Bruner DW. Validation of a Predictive Model for Survival in Patients With Advanced Cancer: Secondary Analysis of RTOG 9714. World J Oncol. 2011 Aug;2(4):181-190. doi: 10.4021/wjon325w. Epub 2011 Aug 24.</citation>
    <PMID>29147245</PMID>
  </reference>
  <reference>
    <citation>Krishnan MS, Epstein-Peterson Z, Chen YH, Tseng YD, Wright AA, Temel JS, Catalano P, Balboni TA. Predicting life expectancy in patients with metastatic cancer receiving palliative radiotherapy: the TEACHH model. Cancer. 2014 Jan 1;120(1):134-41. doi: 10.1002/cncr.28408. Epub 2013 Oct 2. Erratum In: Cancer. 2019 Jul 1;125(13):2325.</citation>
    <PMID>24122413</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tuen Mun Hospital</investigator_affiliation>
    <investigator_full_name>Shing Fung Lee</investigator_full_name>
    <investigator_title>Resident Specialist</investigator_title>
  </responsible_party>
  <keyword>survival</keyword>
  <keyword>cancer</keyword>
  <keyword>palliative</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>prognosis</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Demographic data, and the information required for the prognostic scores will be extracted (e.g. presence of liver metastasis). Also data on the date of birth and death, sex, primary cancer. Data on the primary site of disease were coded using International Classification of Disease version 9.&#xD;
Personal identifier will be deleted to protect patient confidentiality.</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After publication.</ipd_time_frame>
  </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/NCT03797755
org study id: NTWC_Onc_2019
nct id: NCT03797755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many patients with incurable cancer will receive palliative oncological treatment before
      their death, and radiotherapy (RT) is an important element of this. The aim of palliative RT
      is to alleviate symptoms and improve quality of life. An accurate and practical survival
      prediction model for metastatic cancer patient receiving palliative RT can assist the
      decision making (ranging from best supportive treatment alone for expected short survival, to
      dose escalation for potential better disease control).

      The available survival prediction models (such Survival Prediction Score using Number of Risk
      Factors by Chow et al and TEACHH model) have been developed in the Western world. We
      therefore perform a prospective observational study 1) to assess the overall survival of
      patients evaluated for palliative RT at a tertiary hospital in Hong Kong, and 2) to validate
      the prognostic score systems in our population.
observational model: Cohort
time perspective: Prospective
measure: Overall Survival
time frame: 1 year
description: Overall Survival in the studied population
measure: Overall Survival in Each Indication of Palliative Radiotherapy
time frame: 3, 6, 9, 12 months
description: Indications of Palliative Radiotherapy:
The indication will be as follow:
spinal cord compression brain metastases tumor bleeding tumoral mass Cancer pain Superior Vena Cava Syndrome/ Airway compression
measure: Overall Survival by Survival Prediction Model (NRF)
time frame: 3, 6, 9, 12 months
description: Overall Survival by Survival Prediction Score using Number of Risk Factors (NRF)
measure: Overall Survival by Survival Prediction Model (TEACHH)
time frame: 3, 6, 9, 12 months
description: Overall Survival by Survival Prediction Score using TEACHH Model
arm group label: Palliative Cancer Patients
description: Stage IV cancer patients evaluated for palliative radiotherapy.
intervention type: Radiation
intervention name: palliative radiotherapy
description: Radiotherapy for palliating symptoms in stage IV cancer patients
arm group label: Palliative Cancer Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shing Fung Lee, MBBS (HK), FRCR (UK)
role: Principal Investigator
affiliation: Department of Clinical Oncology, New Territory West Cluster, Hospital Authority, Hong Kong
last name: Shing Fung Lee, MBBS (HK), FRCR (UK)
phone: 852 2468 5087
email: leesfm@ha.org.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
citation: Chow E, Harth T, Hruby G, Finkelstein J, Wu J, Danjoux C. How accurate are physicians' clinical predictions of survival and the available prognostic tools in estimating survival times in terminally ill cancer patients? A systematic review. Clin Oncol (R Coll Radiol). 2001;13(3):209-18. doi: 10.1053/clon.2001.9256.
PMID: 11527298
citation: Christakis NA, Lamont EB. Extent and determinants of error in doctors' prognoses in terminally ill patients: prospective cohort study. BMJ. 2000 Feb 19;320(7233):469-72. doi: 10.1136/bmj.320.7233.469.
PMID: 10678857
citation: Gripp S, Mjartan S, Boelke E, Willers R. Palliative radiotherapy tailored to life expectancy in end-stage cancer patients: reality or myth? Cancer. 2010 Jul 1;116(13):3251-6. doi: 10.1002/cncr.25112.
PMID: 20564632
citation: Chow E, Abdolell M, Panzarella T, Harris K, Bezjak A, Warde P, Tannock I. Predictive model for survival in patients with advanced cancer. J Clin Oncol. 2008 Dec 20;26(36):5863-9. doi: 10.1200/JCO.2008.17.1363. Epub 2008 Nov 17.
PMID: 19018082
citation: Peppercorn JM, Smith TJ, Helft PR, Debono DJ, Berry SR, Wollins DS, Hayes DM, Von Roenn JH, Schnipper LE; American Society of Clinical Oncology. American society of clinical oncology statement: toward individualized care for patients with advanced cancer. J Clin Oncol. 2011 Feb 20;29(6):755-60. doi: 10.1200/JCO.2010.33.1744. Epub 2011 Jan 24.
PMID: 21263086
citation: Chow E, James JL, Hartsell W, Scarantino CW, Ivker R, Roach M III, Suh JH, Demas W, Konski A, Bruner DW. Validation of a Predictive Model for Survival in Patients With Advanced Cancer: Secondary Analysis of RTOG 9714. World J Oncol. 2011 Aug;2(4):181-190. doi: 10.4021/wjon325w. Epub 2011 Aug 24.
PMID: 29147245
citation: Krishnan MS, Epstein-Peterson Z, Chen YH, Tseng YD, Wright AA, Temel JS, Catalano P, Balboni TA. Predicting life expectancy in patients with metastatic cancer receiving palliative radiotherapy: the TEACHH model. Cancer. 2014 Jan 1;120(1):134-41. doi: 10.1002/cncr.28408. Epub 2013 Oct 2. Erratum In: Cancer. 2019 Jul 1;125(13):2325.
PMID: 24122413
responsible party type: Principal Investigator
investigator affiliation: Tuen Mun Hospital
investigator full name: Shing Fung Lee
investigator title: Resident Specialist
sharing ipd: Yes
ipd description: Demographic data, and the information required for the prognostic scores will be extracted (e.g. presence of liver metastasis). Also data on the date of birth and death, sex, primary cancer. Data on the primary site of disease were coded using International Classification of Disease version 9.
Personal identifier will be deleted to protect patient confidentiality.
ipd info type: Analytic Code
ipd time frame: After publication.