xml: <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/NCT06022159</url>
    </required_header>
    <id_info>
      <org_study_id>23 SARC 01</org_study_id>
      <nct_id>NCT06022159</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or &quot;Fragile&quot; (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.</brief_title>
    <acronym>HYPOSARC</acronym>
    <official_title>Phase II Study Evaluating Pre- or Post-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or &quot;Fragile&quot; (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Claudius Regaud</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Claudius Regaud</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase II, multicenter, non-randomized study.&#xD;
  &#xD;
        The main objective is to evaluate the treatment with hypofractionated radiation therapy in&#xD;
        neo-adjuvant and adjuvant situations on wound healing in a population of aged patients (≥ 70&#xD;
        years old) or ≥ 65 years of age defined as &quot;fragile&quot; and treated for soft tissue sarcoma.&#xD;
  &#xD;
        A maximum of 70 patients will be included in this study, divided in 2 groups (35 patients per&#xD;
        arms): a neo-adjuvant cohort and an adjuvant cohort.&#xD;
  &#xD;
        In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior&#xD;
        to surgery.&#xD;
  &#xD;
        In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated&#xD;
        radiation therapy.&#xD;
  &#xD;
        Each patient will be followed for up to 3 years after the end of complete treatment&#xD;
        (radiotherapy + surgery or surgery + radiotherapy).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2029</completion_date>
    <primary_completion_date type="Anticipated">September 2026</primary_completion_date>
    <phase>Phase 2</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.</measure>
      <time_frame>6 month for each patient</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patients' disease-free survival defined as the time between the inclusion date and the occurrence of a carcinological event (local recurrence, distant metastasis) or death from any cause.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical complications evaluated according to NCI CTC AE V5 criteria.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healing time defined as the time between the date of surgery and the date of complete healing.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geriatric parameters evaluated using the G-CODE questionnaire.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.</measure>
      <time_frame>3 years for each patient</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Soft Tissue Sarcoma</condition>
    <arm_group>
      <arm_group_label>Neo-adjuvant Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Adjuvant Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.</intervention_name>
      <description>Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy.&#xD;
  Post-operative follow-up: post-operative complications will be followed at 3 and 6 weeks post-surgery.&#xD;
  A visit at 6 months post-surgery will also be carried out to evaluate post-operative complications and late adverse effects of radiotherapy.&#xD;
  Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).</description>
      <arm_group_label>Neo-adjuvant Cohort</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).</intervention_name>
      <description>Post-operative follow-up: postoperative complications will be followed at 3 and 6 weeks post-surgery (before the start of irradiation). Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy.&#xD;
  A 6-month post-surgery check-up will also be carried out to assess post-operative complications and acute side effects of radiotherapy.&#xD;
  Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).</description>
      <arm_group_label>Adjuvant Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.&#xD;
  &#xD;
            2. Indication for neo-adjuvant or adjuvant radiotherapy.&#xD;
  &#xD;
            3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years&#xD;
               with an ECOG of 2 and identified by the investigator as &quot;fragile&quot;.&#xD;
  &#xD;
            4. Patient affiliated to a Social Health Insurance in France.&#xD;
  &#xD;
            5. Patient able to participate and willing to give informed consent prior performance of&#xD;
               any study-related procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Retroperitoneal, ORL and visceral sarcomas.&#xD;
  &#xD;
            2. Previous radiotherapy in the area.&#xD;
  &#xD;
            3. Metastatic disease.&#xD;
  &#xD;
            4. Concomitant or sequential chemotherapy.&#xD;
  &#xD;
            5. Patient requiring total surgery (amputation).&#xD;
  &#xD;
            6. Other cancer under treatment.&#xD;
  &#xD;
            7. Any condition or pathology contraindicating MRI.&#xD;
  &#xD;
            8. Any psychological, familial, geographic or social situation, potentially preventing&#xD;
               the provision of informed consent or compliance to study procedure.&#xD;
  &#xD;
            9. Patients included in another therapeutic interventional trial.&#xD;
  &#xD;
           10. Patient who has forfeited his/her freedom by administrative or legal award or who is&#xD;
               under legal protection (curatorship and guardianship, protection of justice).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Justine ATTAL KHALIFA</last_name>
      <phone>05 31 15 54 38</phone>
      <email>AttalKhalifa.Justine@iuct-oncopole.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institut Bergonie</name>
        <address>
          <city>Bordeaux</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Pauline GILLON</last_name>
        <phone>05 56 33 33 43</phone>
        <email>p.gillon@bordeaux.unicancer.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Oscar Lambret</name>
        <address>
          <city>Lille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Abel CORDOBA LARGO</last_name>
        <phone>03 20 29 59 59</phone>
        <email>a-cordoba@o-lambret.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chu de Limoges</name>
        <address>
          <city>Limoges</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Raphael SERRE</last_name>
        <phone>05 55 05 62 69</phone>
        <email>raphael.serre@chu-limoges.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Leon Berard</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Waisse WAISSI</last_name>
        <phone>04 78 78 28 28</phone>
        <email>waisse.waissi@lyon.unicancer.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Regional Du Cancer de Montpellier</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Carmen LLACER-MOSCARDO</last_name>
        <phone>04 67 61 37 79</phone>
        <email>carmen.llacer@icm.unicancer.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Curie</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sylvie HELFRE</last_name>
        <phone>01 44 32 46 25</phone>
        <email>sylvie.helfre@curie.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chu de Poitiers</name>
        <address>
          <city>Poitiers</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sarah GARCIA MOLINA</last_name>
        <phone>05 49 44 44 44</phone>
        <email>sarah.garcia-molina@chu-poitiers.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut de Cancerologie de L'Ouest</name>
        <address>
          <city>Saint-Herblain</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Augustin MERVOYER</last_name>
        <phone>02 40 67 99 00</phone>
        <email>augustin.mervoyer@ico.unicancer.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chu de Toulouse</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Louis COURTOT</last_name>
        <phone>05 61 77 21 04</phone>
        <email>courtot.l@chu-toulouse.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IUCT-O</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Justine ATTAL KHALIFA</last_name>
        <phone>05 31 15 54 38</phone>
        <email>attalkhalifa.justine@iuct-oncopole.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institut Gustave Roussy</name>
        <address>
          <city>Villejuif</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Cécile LE PECHOUX</last_name>
        <phone>01 42 11 42 11</phone>
        <email>cecile.lepechoux@gustaveroussy.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Soft Tissue Sarcoma</keyword>
    <keyword>Limb soft tissue SARComa</keyword>
    <keyword>Trunk soft tissue SARComa</keyword>
    <keyword>Aged population</keyword>
    <keyword>&quot;Fragile&quot; population</keyword>
    <keyword>hypofractionated radiation therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022159
  org study id: 23 SARC 01
  nct id: NCT06022159
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a phase II, multicenter, non-randomized study.
  
        The main objective is to evaluate the treatment with hypofractionated radiation therapy in
        neo-adjuvant and adjuvant situations on wound healing in a population of aged patients (≥ 70
        years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma.
  
        A maximum of 70 patients will be included in this study, divided in 2 groups (35 patients per
        arms): a neo-adjuvant cohort and an adjuvant cohort.
  
        In the neo-adjuvant cohort, patients will receive an hypofractionated radiation therapy prior
        to surgery.
  
        In the adjuvant cohort, patients will undergo a surgery before receive the hypofractionated
        radiation therapy.
  
        Each patient will be followed for up to 3 years after the end of complete treatment
        (radiotherapy + surgery or surgery + radiotherapy).
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
  time frame: 6 month for each patient
  measure: Patients' disease-free survival defined as the time between the inclusion date and the occurrence of a carcinological event (local recurrence, distant metastasis) or death from any cause.
  time frame: 3 years for each patient
  measure: Surgical complications evaluated according to NCI CTC AE V5 criteria.
  time frame: 3 years for each patient
  measure: Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
  time frame: 3 years for each patient
  measure: Healing time defined as the time between the date of surgery and the date of complete healing.
  time frame: 3 years for each patient
  measure: Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
  time frame: 3 years for each patient
  measure: Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
  time frame: 3 years for each patient
  measure: Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
  time frame: 3 years for each patient
  measure: Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
  time frame: 3 years for each patient
  measure: Geriatric parameters evaluated using the G-CODE questionnaire.
  time frame: 3 years for each patient
  measure: Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
  time frame: 3 years for each patient
  arm group label: Neo-adjuvant Cohort
  arm group type: Experimental
  arm group label: Adjuvant Cohort
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Patients will receive the hypofractionated radiation therapy (30 Gy in 5 fractions) prior to surgery.
  description: Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy.
  Post-operative follow-up: post-operative complications will be followed at 3 and 6 weeks post-surgery.
  A visit at 6 months post-surgery will also be carried out to evaluate post-operative complications and late adverse effects of radiotherapy.
  Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).
  arm group label: Neo-adjuvant Cohort
  intervention type: Procedure
  intervention name: Patient will undergo surgery before receive the adjuvant hypofractionated radiation therapy (40 Gy in 15 fractions).
  description: Post-operative follow-up: postoperative complications will be followed at 3 and 6 weeks post-surgery (before the start of irradiation). Early post-radiotherapy toxicity will then be assessed 1 month after the end of radiotherapy.
  A 6-month post-surgery check-up will also be carried out to assess post-operative complications and acute side effects of radiotherapy.
  Long-term follow-up would also be performed every 6 months from the 6-month post-surgery visit up to 3 years post-surgery (M12, M18, M24, M30 and M36).
  arm group label: Adjuvant Cohort
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Justine ATTAL KHALIFA
  phone: 05 31 15 54 38
  email: AttalKhalifa.Justine@iuct-oncopole.fr
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  country: France
  responsible party type: Sponsor
  mesh term: Sarcoma