<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/NCT02994914</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0902</org_study_id>
    <secondary_id>2016-A01469-42</secondary_id>
    <nct_id>NCT02994914</nct_id>
  </id_info>
  <brief_title>GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance</brief_title>
  <acronym>GERABEL</acronym>
  <official_title>GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Antoine Lacassagne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental&#xD;
      Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale,&#xD;
      Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and &quot; timed get up&#xD;
      and go &quot; tests) for elderly breast cancer patients. The score obtained at this evaluation&#xD;
      will determine the radiotherapy scheme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is the most frequent cancer for elderly women and represents the first&#xD;
      mortality cause for them. Breast cancer incidence increases for elderly women and will become&#xD;
      a major public health problem in the next years.&#xD;
&#xD;
      The principal therapeutic solution is the partial mastectomy associated to radiotherapy.&#xD;
      However, the radiotherapy scheme and its role are debated for elderly patients. Hypo&#xD;
      fractionated radiotherapy could be considered as an advantageous option.&#xD;
&#xD;
      The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are&#xD;
      major cons. Thereby, for elderly patients, the selection of patients who will benefit from a&#xD;
      shorter treatment could be really difficult. It would be interesting to define an objective&#xD;
      scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays,&#xD;
      onco geriatric evaluations are used to decide some treatment's decision, but no study&#xD;
      compared different orientated radiotherapy schemes.&#xD;
&#xD;
      The present study proposes an onco geriatric evaluation leading to a score according to seven&#xD;
      tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State&#xD;
      Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness&#xD;
      Rating Scale-Geriatric, and &quot; timed get up and go &quot; tests). The score will then determine an&#xD;
      adapted radiotherapy scheme.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low rythm of inclusions&#xD;
  </why_stopped>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">June 26, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of the tolerance</measure>
    <time_frame>Month 6</time_frame>
    <description>Tolerance is considered as &quot; bad &quot; if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as &quot;correct&quot; in the other cases.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerance</measure>
    <time_frame>Month 6</time_frame>
    <description>Specific tolerance will be evaluated by the number of radiation-induced toxicities (Common Terminology Criteria for Adverse Events 4.4) of I, II, III, and IV grades.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>Month 6</time_frame>
    <description>Quality of life will be assessed with the difference between the Quality of Life Questionnaire 30 of the European Organisation for Research and Treatment of Cancer (EORTC) score obtained before the radiotherapy and 6 months after the end of the radiation therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiotherapy compliance</measure>
    <time_frame>Month 6</time_frame>
    <description>Compliance is considered as &quot;bad&quot; if the treatment plan is interrupted for at least one day (for medical reason). Compliance is considered as &quot;correct&quot; in the other cases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between tolerance and distance from the therapeutic center</measure>
    <time_frame>Month 6</time_frame>
    <description>Correlation will potentially be established between patient general tolerance and the distance between home and radio therapeutic center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between tolerance and way of transport</measure>
    <time_frame>Month 6</time_frame>
    <description>Correlation will potentially be established between patient general tolerance and the way of transport used by the patient to go to the therapeutic center.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between tolerance and the number of concomitant treatments</measure>
    <time_frame>Month 6</time_frame>
    <description>Correlation will potentially be established between patient general tolerance and the number of concomitant treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between tolerance and the nature of concomitant treatments</measure>
    <time_frame>Month 6</time_frame>
    <description>Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between tolerance and the supportive cares</measure>
    <time_frame>Month 6</time_frame>
    <description>Correlation will potentially be established between patient general tolerance and the supportive cares performed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Score of the Onco Geriatric Evaluation between 200 et 160</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the score obtained with the onco geriatric evaluation, patients with a score between 200 and 160 will receive a normo fractionated radiotherapy (66 Grays in 33 fractions). This scheme of radiotherapy is already used in the clinical practice, but not allocated according to a score obtained at an oncogeriatric evaluation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Score of the Onco Geriatric Evaluation between 159 et 120</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the score obtained with the onco geriatric evaluation, patients with a score between 159 and 120 will receive an hypo fractionated radiotherapy (42,56 Grays in 16 fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Score of the Onco Geriatric Evaluation inferior to 119</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the score obtained with the onco geriatric evaluation, patients with a score inferior to 119 will receive a large hypo fractionated radiotherapy (30 Grays in 5 weekly fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Onco Geriatric Evaluation</intervention_name>
    <description>Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and &quot; timed get up and go &quot; tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.</description>
    <arm_group_label>Score of the Onco Geriatric Evaluation between 159 et 120</arm_group_label>
    <arm_group_label>Score of the Onco Geriatric Evaluation between 200 et 160</arm_group_label>
    <arm_group_label>Score of the Onco Geriatric Evaluation inferior to 119</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman more than 70 years old,&#xD;
&#xD;
          -  Patient carrying a breast cancer proven histologically and treated by radiotherapy in&#xD;
             curative intent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Man,&#xD;
&#xD;
          -  Patient with metastatic cancer,&#xD;
&#xD;
          -  Patient with impossible follow-up at 6 months (planned relocation, patient support in&#xD;
             another Center),&#xD;
&#xD;
          -  Patient under protection of justice or unable to give consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Magné, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie Lucien Neuwirth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Emile Roux</name>
      <address>
        <city>Le Puy-en-Velay</city>
        <zip>43000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupement Hospitalier Portes de Provence</name>
      <address>
        <city>Montelimar</city>
        <zip>26216</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest en Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Onco Geriatric Evaluation</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Hypo fractionated radiotherapy</keyword>
  <keyword>Normo fractionated radiotherapy</keyword>
  <keyword>Large hypo fractionated radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT02994914
org study id: 2016-0902
secondary id: 2016-A01469-42
nct id: NCT02994914
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental
      Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale,
      Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up
      and go " tests) for elderly breast cancer patients. The score obtained at this evaluation
      will determine the radiotherapy scheme.
Breast cancer is the most frequent cancer for elderly women and represents the first
      mortality cause for them. Breast cancer incidence increases for elderly women and will become
      a major public health problem in the next years.

      The principal therapeutic solution is the partial mastectomy associated to radiotherapy.
      However, the radiotherapy scheme and its role are debated for elderly patients. Hypo
      fractionated radiotherapy could be considered as an advantageous option.

      The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are
      major cons. Thereby, for elderly patients, the selection of patients who will benefit from a
      shorter treatment could be really difficult. It would be interesting to define an objective
      scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays,
      onco geriatric evaluations are used to decide some treatment's decision, but no study
      compared different orientated radiotherapy schemes.

      The present study proposes an onco geriatric evaluation leading to a score according to seven
      tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State
      Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness
      Rating Scale-Geriatric, and " timed get up and go " tests). The score will then determine an
      adapted radiotherapy scheme.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Measure of the tolerance
time frame: Month 6
description: Tolerance is considered as " bad " if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as "correct" in the other cases.
measure: Tolerance
time frame: Month 6
description: Specific tolerance will be evaluated by the number of radiation-induced toxicities (Common Terminology Criteria for Adverse Events 4.4) of I, II, III, and IV grades.
measure: Quality of Life Questionnaire
time frame: Month 6
description: Quality of life will be assessed with the difference between the Quality of Life Questionnaire 30 of the European Organisation for Research and Treatment of Cancer (EORTC) score obtained before the radiotherapy and 6 months after the end of the radiation therapy.
measure: Radiotherapy compliance
time frame: Month 6
description: Compliance is considered as "bad" if the treatment plan is interrupted for at least one day (for medical reason). Compliance is considered as "correct" in the other cases.
measure: Correlation between tolerance and distance from the therapeutic center
time frame: Month 6
description: Correlation will potentially be established between patient general tolerance and the distance between home and radio therapeutic center.
measure: Correlation between tolerance and way of transport
time frame: Month 6
description: Correlation will potentially be established between patient general tolerance and the way of transport used by the patient to go to the therapeutic center.
measure: Correlation between tolerance and the number of concomitant treatments
time frame: Month 6
description: Correlation will potentially be established between patient general tolerance and the number of concomitant treatments.
measure: Correlation between tolerance and the nature of concomitant treatments
time frame: Month 6
description: Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments.
measure: Correlation between tolerance and the supportive cares
time frame: Month 6
description: Correlation will potentially be established between patient general tolerance and the supportive cares performed.
arm group label: Score of the Onco Geriatric Evaluation between 200 et 160
arm group type: Experimental
description: According to the score obtained with the onco geriatric evaluation, patients with a score between 200 and 160 will receive a normo fractionated radiotherapy (66 Grays in 33 fractions). This scheme of radiotherapy is already used in the clinical practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
arm group label: Score of the Onco Geriatric Evaluation between 159 et 120
arm group type: Experimental
description: According to the score obtained with the onco geriatric evaluation, patients with a score between 159 and 120 will receive an hypo fractionated radiotherapy (42,56 Grays in 16 fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
arm group label: Score of the Onco Geriatric Evaluation inferior to 119
arm group type: Experimental
description: According to the score obtained with the onco geriatric evaluation, patients with a score inferior to 119 will receive a large hypo fractionated radiotherapy (30 Grays in 5 weekly fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
intervention type: Other
intervention name: Onco Geriatric Evaluation
description: Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.
arm group label: Score of the Onco Geriatric Evaluation between 159 et 120
arm group label: Score of the Onco Geriatric Evaluation between 200 et 160
arm group label: Score of the Onco Geriatric Evaluation inferior to 119
criteria: 
gender: Female
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas Magné, PhD
role: Principal Investigator
affiliation: Institut de Cancérologie Lucien Neuwirth
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No