<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/NCT02986503</url>
  </required_header>
  <id_info>
    <org_study_id>EURO-B.O.S.S</org_study_id>
    <nct_id>NCT02986503</nct_id>
  </id_info>
  <brief_title>European Study in Bone Sarcoma Patients Over 40 Years</brief_title>
  <acronym>EUROBOSS</acronym>
  <official_title>A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Italian Sarcoma Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scandinavian Sarcoma Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cooperative Osteosarcoma Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Italian Sarcoma Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a first step of a process to establish the standard chemotherapy treatment with&#xD;
      the aim to improve outcome for patients with these rare tumours. For this reason the study&#xD;
      will be non-controlled clinical trial.&#xD;
&#xD;
      In this regard, the study aims to determine the feasibility of intensive chemotherapy in this&#xD;
      age group, and/or separate efficacy analyses according to the different histologic categories&#xD;
      and whether the number of patients recruited by the co-operating groups permits future&#xD;
      randomised studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wide surgical removal of the tumor with the addition of a systemic treatment based on the&#xD;
      antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide,&#xD;
      Methotrexate). The use of radiation therapy will be given to patients with unresectable&#xD;
      tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor.&#xD;
      The addition of radiation therapy can not compensate for an adequate surgical treatment.&#xD;
&#xD;
      All the patients eligible for the study will receive the planned systemic treatment.&#xD;
      Depending on clinical features, and feasibility of adequate surgical removal of the tumor,&#xD;
      patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment&#xD;
      or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an&#xD;
      adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2002</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Event-free survival</measure>
    <time_frame>from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months.</time_frame>
    <description>Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months</time_frame>
    <description>Survival without progression of disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months</time_frame>
    <description>Survival without disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis-free survival</measure>
    <time_frame>from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months</time_frame>
    <description>Survival without metastasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>from the date of randomization until the end of the study, assessed every 3 months, up to 168 month</time_frame>
    <description>Global patients survival evaluation after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy toxicity</measure>
    <time_frame>Every 3 weeks</time_frame>
    <description>Number and grade of adverse events related to the study treatments</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Spindle Cell Sarcoma of Bone</condition>
  <condition>Osteosarcoma</condition>
  <arm_group>
    <arm_group_label>Chemotherapy for Good responder</arm_group_label>
    <description>Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy for Poor responder</arm_group_label>
    <description>Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin+cisplatin+ifosfamide</intervention_name>
    <description>Chemotherapy for Good responder high grade osteosarcoma</description>
    <arm_group_label>Chemotherapy for Good responder</arm_group_label>
    <other_name>Doxorubicin,cisplatin,ifosfamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin+cisplatin+ifosfamide+methotrexate</intervention_name>
    <description>Chemotherapy for Poor responder high grade osteosarcoma</description>
    <arm_group_label>Chemotherapy for Poor responder</arm_group_label>
    <other_name>Doxorubicin,cisplatin,ifosfamide,methotrexate</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients older than 40 years with highly malignant spindle cell sarcoma of bone&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.&#xD;
&#xD;
          2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary),&#xD;
             fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated&#xD;
             chondrosarcoma, angiosarcoma.&#xD;
&#xD;
          3. Age: 41 - 65&#xD;
&#xD;
          4. Normal bone marrow, hepatic, cardiac and renal function&#xD;
&#xD;
          5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide&#xD;
&#xD;
          6. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planned chemotherapy and/or follow-up not feasible&#xD;
&#xD;
          2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs,&#xD;
             included in the present protocol&#xD;
&#xD;
          3. Previous chemotherapy treatment for the current tumor&#xD;
&#xD;
          4. White blood count &lt; 3.0 x 109/L, and platelets &lt; 100 x 109/L&#xD;
&#xD;
          5. Creatinine clearance &lt; 70 ml/min&#xD;
&#xD;
          6. Left ventricular ejection fraction &lt; 55% or fractional shortening rate of the left&#xD;
             ventricle &lt;28%&#xD;
&#xD;
          7. Serum transaminases and bilirubin &gt; 2 times the normal values&#xD;
&#xD;
          8. ECOG performance status &gt; 2&#xD;
&#xD;
          9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma&#xD;
             and Ewing's family tumors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefano Ferrari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Italian Sarcoma Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cooperative Osteosarcoma Study Group</name>
      <address>
        <city>Stuttgart</city>
        <zip>D-70176</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scandinavian Sarcoma Group</name>
      <address>
        <city>Lund</city>
        <zip>SE-221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.ssg-org.net/wp-content/uploads/2011/05/Euroboss1.pdf</url>
    <description>Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 years</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Osteosarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Ifosfamide</mesh_term>
    <mesh_term>Isophosphamide mustard</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov</ipd_description>
  </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/NCT02986503
org study id: EURO-B.O.S.S
nct id: NCT02986503
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The study is a first step of a process to establish the standard chemotherapy treatment with
      the aim to improve outcome for patients with these rare tumours. For this reason the study
      will be non-controlled clinical trial.

      In this regard, the study aims to determine the feasibility of intensive chemotherapy in this
      age group, and/or separate efficacy analyses according to the different histologic categories
      and whether the number of patients recruited by the co-operating groups permits future
      randomised studies.
Wide surgical removal of the tumor with the addition of a systemic treatment based on the
      antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide,
      Methotrexate). The use of radiation therapy will be given to patients with unresectable
      tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor.
      The addition of radiation therapy can not compensate for an adequate surgical treatment.

      All the patients eligible for the study will receive the planned systemic treatment.
      Depending on clinical features, and feasibility of adequate surgical removal of the tumor,
      patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment
      or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an
      adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).
time perspective: Prospective
measure: Event-free survival
time frame: from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months.
description: Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)
measure: Progression-free survival
time frame: from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months
description: Survival without progression of disease
measure: Disease-free survival
time frame: from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months
description: Survival without disease
measure: Metastasis-free survival
time frame: from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months
description: Survival without metastasis
measure: Overall survival
time frame: from the date of randomization until the end of the study, assessed every 3 months, up to 168 month
description: Global patients survival evaluation after treatment
measure: Chemotherapy toxicity
time frame: Every 3 weeks
description: Number and grade of adverse events related to the study treatments
arm group label: Chemotherapy for Good responder
description: Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma
arm group label: Chemotherapy for Poor responder
description: Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma
intervention type: Drug
intervention name: Doxorubicin+cisplatin+ifosfamide
description: Chemotherapy for Good responder high grade osteosarcoma
arm group label: Chemotherapy for Good responder
other name: Doxorubicin,cisplatin,ifosfamide
intervention type: Drug
intervention name: Doxorubicin+cisplatin+ifosfamide+methotrexate
description: Chemotherapy for Poor responder high grade osteosarcoma
arm group label: Chemotherapy for Poor responder
other name: Doxorubicin,cisplatin,ifosfamide,methotrexate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 41 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stefano Ferrari, MD
role: Principal Investigator
affiliation: Italian Sarcoma Group
facility: 
facility: 
facility: 
country: Germany
country: Italy
country: Sweden
url: http://www.ssg-org.net/wp-content/uploads/2011/05/Euroboss1.pdf
description: Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 years
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Osteosarcoma
mesh term: Cisplatin
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Methotrexate
mesh term: Ifosfamide
mesh term: Isophosphamide mustard
sharing ipd: Yes
ipd description: Anonymized results will be available upon request at the end of the study and public available into the repository systems like Clinicaltrial.gov