<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/NCT03023124</url>
  </required_header>
  <id_info>
    <org_study_id>ISG STRADA</org_study_id>
    <nct_id>NCT03023124</nct_id>
  </id_info>
  <brief_title>Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor</brief_title>
  <acronym>STRADA</acronym>
  <official_title>Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Italian Sarcoma Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Italian Sarcoma Group</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Phase II randomized study for the comparison of trabectedin versus doxorubicin plus&#xD;
      dacarbazine in patients with advanced solitary fibrous tumor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or&#xD;
      doxorubicin plus dacarbazine.&#xD;
&#xD;
      In case of progression or unacceptable toxicity while under the experimental treatment prior&#xD;
      to the completion of the 6 cycles, the patients will be offered to cross to the other arm&#xD;
      (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 4, 2018</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Tumor Response Rate</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 54 weeks.</time_frame>
    <description>evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Choi Response Rate</measure>
    <time_frame>week 6, week 12, week 18, then every 12 weeks up to 54 weeks</time_frame>
    <description>Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From enrollment up to 5 years</time_frame>
    <description>Time from the date of enrollment to date of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks</time_frame>
    <description>Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR)</measure>
    <time_frame>week 6, week 12, week 18, then every 12 weeks up to 54 weeks</time_frame>
    <description>Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate by RECIST after the cross over</measure>
    <time_frame>week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks</time_frame>
    <description>Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death</measure>
    <time_frame>From date of cross over until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks</time_frame>
    <description>Survival free of progressive disease evaluated from</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety according to Common Terminology Criteria for Adverse Events (CTCAE)</measure>
    <time_frame>From enrollment every 3 weeks up to 54 weeks</time_frame>
    <description>Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Solitary Fibrous Tumors</condition>
  <arm_group>
    <arm_group_label>Trabectedin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adriamycin and Dacarbazine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adriamycin: 75 mg/m2/day, bolus, day 1 every 21 days for 6 cycles Dacarbazine: 400 mg/m2/day, days 1, 2 every 21 days for 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trabectedin</intervention_name>
    <description>Treatment with trabectedin repeated every 21 days for 6 cycles</description>
    <arm_group_label>Trabectedin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adriamycin</intervention_name>
    <description>Treatment with Adriamycin at day 1 every 21 days for 6 cycles</description>
    <arm_group_label>Adriamycin and Dacarbazine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <description>Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles</description>
    <arm_group_label>Adriamycin and Dacarbazine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient or legal representative must be able to read and understand the informed&#xD;
             consent form (ICF) and must have been willing to give written informed consent and any&#xD;
             locally required authorisation before any study-specific procedures, including&#xD;
             screening evaluations, sampling, and analyses.&#xD;
&#xD;
          2. Age ≥18 years&#xD;
&#xD;
          3. Histological centrally and molecularly confirmed diagnosis of solitary fibrous tumor&#xD;
             (inclusive of the last available tumor sample)&#xD;
&#xD;
          4. Locally advanced disease (i.e. surgical resection of local disease unfeasible&#xD;
             radically, or unaccepted by the patient, or amenable to become less demolitive, or&#xD;
             feasible, or easier, after cytoreduction) and/or metastatic disease&#xD;
&#xD;
          5. Measurable or evaluable disease with RECIST&#xD;
&#xD;
          6. Evidence of progression by RECIST during the 6 months before study entry&#xD;
&#xD;
          7. Patients must be cytotoxic chemotherapy naïve (patients treated with&#xD;
             neoadjuvant/adjuvant chemotherapy cannot be included) or could have received a&#xD;
             previous target agent in front-line setting.&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2&#xD;
&#xD;
          9. Adequate bone marrow function&#xD;
&#xD;
         10. Adequate organ function&#xD;
&#xD;
         11. Cardiac ejection fraction ≥50% as measured by echocardiogram&#xD;
&#xD;
         12. Female patients of child-bearing potential must have negative pregnancy test within 7&#xD;
             days before initiation each cycle of chemotherapy. Post-menopausal women must be&#xD;
             amenorrhoeic for at least 12 months to be considered of non-childbearing potential.&#xD;
             Male and female patients of reproductive potential must agree to employ an effective&#xD;
             method of birth control throughout the study.&#xD;
&#xD;
         13. No history of arterial and/or venous thromboembolic event within the previous 12&#xD;
             months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any prior treatment with cytotoxic chemotherapy&#xD;
&#xD;
          2. &gt;1 line of anticancer targeted agents&#xD;
&#xD;
          3. Previous treatment with any other investigational or not investigational agents within&#xD;
             14 days of first day of study drug dosing&#xD;
&#xD;
          4. Previous treatment with radiation therapy within 14 days of first day of study drug&#xD;
             dosing, or patients who have not recovered from adverse events due to agents&#xD;
             previously administered&#xD;
&#xD;
          5. Previous radiotherapy to 25 % of the bone marrow&#xD;
&#xD;
          6. Major surgery within 4 weeks prior to study entry&#xD;
&#xD;
          7. Other primary malignancy with &lt;5 years clinically assessed disease-free interval,&#xD;
             except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged&#xD;
             to entail a low risk of relapse&#xD;
&#xD;
          8. Pregnancy or breast feeding&#xD;
&#xD;
          9. Cardiovascular diseases resulting in a New York Heart Association Functional Status &gt;2&#xD;
             (24). Medical history of a myocardial infarction &lt; 6 months prior to initiation of&#xD;
             study treatment&#xD;
&#xD;
         10. Medical history of arterial thrombotic or embolic events such as cerebrovascular&#xD;
             accident (including transient ischemic attacks), or pulmonary embolism within 6 months&#xD;
             prior to the initiation of study treatment&#xD;
&#xD;
         11. Known history of human immunodeficiency virus infection&#xD;
&#xD;
         12. Active or chronic hepatitis B or C requiring treatment with antiviral therapy&#xD;
&#xD;
         13. Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 4.0) within 4&#xD;
             weeks prior to the initiation of study treatment&#xD;
&#xD;
         14. Evidence of any other serious or unstable illness, or medical, psychological, or&#xD;
             social condition, that could jeopardize the safety of the subject and/or his/her&#xD;
             compliance with study procedures, or may interfere with the subject's participation in&#xD;
             the study or evaluation of the study results&#xD;
&#xD;
         15. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in&#xD;
             the formulation of the study drugs&#xD;
&#xD;
         16. Expected non-compliance to medical regimens&#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>Silvia Stacchiotti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Italian Sarcoma Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emanuela Marchesi</last_name>
    <phone>+390516366</phone>
    <phone_ext>470</phone_ext>
    <email>emanuela.marchesi@ior.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nuovo Ospedale di Prato</name>
      <address>
        <city>Prato</city>
        <state>Firenze</state>
        <zip>59100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giacomo G. Baldi, MD</last_name>
      <phone>0039057443</phone>
      <phone_ext>4766</phone_ext>
      <email>giacomogiulio.baldi@uslcentro.toscana.it</email>
    </contact>
    <investigator>
      <last_name>Giacomo G. Baldi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Silvia Stacchiotti, MD</last_name>
      <email>silvia.stacchiotti@istitutotumori.mi.it</email>
    </contact>
    <investigator>
      <last_name>Silvia Stacchiotti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Biomedico</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno Vincenzi, MD</last_name>
      <phone>+3902225411123</phone>
      <email>b.vincenzi@unicampus.it</email>
    </contact>
    <investigator>
      <last_name>Bruno Vincenzi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emanuela Palmerini, MD</last_name>
      <phone>+390516366</phone>
      <phone_ext>199</phone_ext>
      <email>emanuela.palmerini@ior.it</email>
    </contact>
    <contact_backup>
      <last_name>Michela Pierini, PhD</last_name>
      <phone>+390516366</phone>
      <phone_ext>668</phone_ext>
      <email>michela.pierini@ior.it</email>
    </contact_backup>
    <investigator>
      <last_name>Emanuela Palmerini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -</name>
      <address>
        <city>Candiolo</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Giaccone</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Badalamenti, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Dagrada GP, Spagnuolo RD, Mauro V, Tamborini E, Cesana L, Gronchi A, Stacchiotti S, Pierotti MA, Negri T, Pilotti S. Solitary fibrous tumors: loss of chimeric protein expression and genomic instability mark dedifferentiation. Mod Pathol. 2015 Aug;28(8):1074-83. doi: 10.1038/modpathol.2015.70. Epub 2015 May 29.</citation>
    <PMID>26022454</PMID>
  </reference>
  <reference>
    <citation>Beadle GF, Hillcoat BL. Treatment of advanced malignant hemangiopericytoma with combination adriamycin and DTIC: a report of four cases. J Surg Oncol. 1983 Mar;22(3):167-70. doi: 10.1002/jso.2930220306.</citation>
    <PMID>6682161</PMID>
  </reference>
  <reference>
    <citation>Stacchiotti S, Libertini M, Negri T, Palassini E, Gronchi A, Fatigoni S, Poletti P, Vincenzi B, Dei Tos AP, Mariani L, Pilotti S, Casali PG. Response to chemotherapy of solitary fibrous tumour: a retrospective study. Eur J Cancer. 2013 Jul;49(10):2376-83. doi: 10.1016/j.ejca.2013.03.017. Epub 2013 Apr 6.</citation>
    <PMID>23566418</PMID>
  </reference>
  <reference>
    <citation>Stacchiotti S, Tortoreto M, Bozzi F, Tamborini E, Morosi C, Messina A, Libertini M, Palassini E, Cominetti D, Negri T, Gronchi A, Pilotti S, Zaffaroni N, Casali PG. Dacarbazine in solitary fibrous tumor: a case series analysis and preclinical evidence vis-a-vis temozolomide and antiangiogenics. Clin Cancer Res. 2013 Sep 15;19(18):5192-201. doi: 10.1158/1078-0432.CCR-13-0776. Epub 2013 Jul 25.</citation>
    <PMID>23888069</PMID>
  </reference>
  <reference>
    <citation>Park MS, Ravi V, Conley A, Patel SR, Trent JC, Lev DC, Lazar AJ, Wang WL, Benjamin RS, Araujo DM. The role of chemotherapy in advanced solitary fibrous tumors: a retrospective analysis. Clin Sarcoma Res. 2013 May 11;3(1):7. doi: 10.1186/2045-3329-3-7.</citation>
    <PMID>23663788</PMID>
  </reference>
  <reference>
    <citation>Chaigneau L, Kalbacher E, Thiery-Vuillemin A, Fagnoni-Legat C, Isambert N, Aherfi L, Pauchot J, Delroeux D, Servagi-Vernat S, Mansi L, Pivot X. Efficacy of trabectedin in metastatic solitary fibrous tumor. Rare Tumors. 2011 Jul 11;3(3):e29. doi: 10.4081/rt.2011.e29. Epub 2011 Jul 18.</citation>
    <PMID>22066036</PMID>
  </reference>
  <reference>
    <citation>Khalifa J, Ouali M, Chaltiel L, Le Guellec S, Le Cesne A, Blay JY, Cousin P, Chaigneau L, Bompas E, Piperno-Neumann S, Bui-Nguyen B, Rios M, Delord JP, Penel N, Chevreau C. Efficacy of trabectedin in malignant solitary fibrous tumors: a retrospective analysis from the French Sarcoma Group. BMC Cancer. 2015 Oct 15;15:700. doi: 10.1186/s12885-015-1697-8.</citation>
    <PMID>26472661</PMID>
  </reference>
  <reference>
    <citation>Domont J, Massard C, Lassau N, Armand JP, Le Cesne A, Soria JC. Hemangiopericytoma and antiangiogenic therapy: clinical benefit of antiangiogenic therapy (sorafenib and sunitinib) in relapsed malignant haemangioperyctoma /solitary fibrous tumour. Invest New Drugs. 2010 Apr;28(2):199-202. doi: 10.1007/s10637-009-9249-1. Epub 2009 Apr 8. No abstract available.</citation>
    <PMID>19352594</PMID>
  </reference>
  <reference>
    <citation>Park MS, Patel SR, Ludwig JA, Trent JC, Conrad CA, Lazar AJ, Wang WL, Boonsirikamchai P, Choi H, Wang X, Benjamin RS, Araujo DM. Activity of temozolomide and bevacizumab in the treatment of locally advanced, recurrent, and metastatic hemangiopericytoma and malignant solitary fibrous tumor. Cancer. 2011 Nov 1;117(21):4939-47. doi: 10.1002/cncr.26098. Epub 2011 Apr 8.</citation>
    <PMID>21480200</PMID>
  </reference>
  <reference>
    <citation>Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.</citation>
    <PMID>24005614</PMID>
  </reference>
  <reference>
    <citation>Stacchiotti S, Tortoreto M, Baldi GG, Grignani G, Toss A, Badalamenti G, Cominetti D, Morosi C, Dei Tos AP, Festinese F, Fumagalli E, Provenzano S, Gronchi A, Pennacchioli E, Negri T, Dagrada GP, Spagnuolo RD, Pilotti S, Casali PG, Zaffaroni N. Preclinical and clinical evidence of activity of pazopanib in solitary fibrous tumour. Eur J Cancer. 2014 Nov;50(17):3021-8. doi: 10.1016/j.ejca.2014.09.004. Epub 2014 Sep 27.</citation>
    <PMID>25269954</PMID>
  </reference>
  <reference>
    <citation>Martin-Broto J, Pousa AL, de Las Penas R, Garcia Del Muro X, Gutierrez A, Martinez-Trufero J, Cruz J, Alvarez R, Cubedo R, Redondo A, Maurel J, Carrasco JA, Lopez-Martin JA, Sala A, Meana JA, Ramos R, Martinez-Serra J, Lopez-Guerrero JA, Sevilla I, Balana C, Vaz A, De Juan A, Alemany R, Poveda A. Randomized Phase II Study of Trabectedin and Doxorubicin Compared With Doxorubicin Alone as First-Line Treatment in Patients With Advanced Soft Tissue Sarcomas: A Spanish Group for Research on Sarcoma Study. J Clin Oncol. 2016 Jul 1;34(19):2294-302. doi: 10.1200/JCO.2015.65.3329. Epub 2016 May 16.</citation>
    <PMID>27185843</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>Solitary Fibrous Tumors</mesh_term>
    <mesh_term>Hemangiopericytoma</mesh_term>
    <mesh_term>Neoplasms, Fibrous Tissue</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
    <mesh_term>Trabectedin</mesh_term>
  </intervention_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/NCT03023124
org study id: ISG STRADA
nct id: NCT03023124
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Phase II randomized study for the comparison of trabectedin versus doxorubicin plus
      dacarbazine in patients with advanced solitary fibrous tumor
Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or
      doxorubicin plus dacarbazine.

      In case of progression or unacceptable toxicity while under the experimental treatment prior
      to the completion of the 6 cycles, the patients will be offered to cross to the other arm
      (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Tumor Response Rate
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 54 weeks.
description: evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1
measure: Choi Response Rate
time frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks
description: Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.
measure: Overall Survival (OS)
time frame: From enrollment up to 5 years
description: Time from the date of enrollment to date of death
measure: Progression Free Survival (PFS)
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
description: Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death
measure: Clinical Benefit Rate (CBR)
time frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks
description: Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months
measure: Response rate by RECIST after the cross over
time frame: week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks
description: Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over
measure: Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death
time frame: From date of cross over until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
description: Survival free of progressive disease evaluated from
measure: Safety according to Common Terminology Criteria for Adverse Events (CTCAE)
time frame: From enrollment every 3 weeks up to 54 weeks
description: Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03
arm group label: Trabectedin
arm group type: Experimental
description: trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles
arm group label: Adriamycin and Dacarbazine
arm group type: Experimental
description: Adriamycin: 75 mg/m2/day, bolus, day 1 every 21 days for 6 cycles Dacarbazine: 400 mg/m2/day, days 1, 2 every 21 days for 6 cycles
intervention type: Drug
intervention name: Trabectedin
description: Treatment with trabectedin repeated every 21 days for 6 cycles
arm group label: Trabectedin
intervention type: Drug
intervention name: Adriamycin
description: Treatment with Adriamycin at day 1 every 21 days for 6 cycles
arm group label: Adriamycin and Dacarbazine
intervention type: Drug
intervention name: Dacarbazine
description: Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles
arm group label: Adriamycin and Dacarbazine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Silvia Stacchiotti, MD
role: Principal Investigator
affiliation: Italian Sarcoma Group
last name: Emanuela Marchesi
phone: +390516366
phone ext: 470
email: emanuela.marchesi@ior.it
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
country: Italy
citation: Dagrada GP, Spagnuolo RD, Mauro V, Tamborini E, Cesana L, Gronchi A, Stacchiotti S, Pierotti MA, Negri T, Pilotti S. Solitary fibrous tumors: loss of chimeric protein expression and genomic instability mark dedifferentiation. Mod Pathol. 2015 Aug;28(8):1074-83. doi: 10.1038/modpathol.2015.70. Epub 2015 May 29.
PMID: 26022454
citation: Beadle GF, Hillcoat BL. Treatment of advanced malignant hemangiopericytoma with combination adriamycin and DTIC: a report of four cases. J Surg Oncol. 1983 Mar;22(3):167-70. doi: 10.1002/jso.2930220306.
PMID: 6682161
citation: Stacchiotti S, Libertini M, Negri T, Palassini E, Gronchi A, Fatigoni S, Poletti P, Vincenzi B, Dei Tos AP, Mariani L, Pilotti S, Casali PG. Response to chemotherapy of solitary fibrous tumour: a retrospective study. Eur J Cancer. 2013 Jul;49(10):2376-83. doi: 10.1016/j.ejca.2013.03.017. Epub 2013 Apr 6.
PMID: 23566418
citation: Stacchiotti S, Tortoreto M, Bozzi F, Tamborini E, Morosi C, Messina A, Libertini M, Palassini E, Cominetti D, Negri T, Gronchi A, Pilotti S, Zaffaroni N, Casali PG. Dacarbazine in solitary fibrous tumor: a case series analysis and preclinical evidence vis-a-vis temozolomide and antiangiogenics. Clin Cancer Res. 2013 Sep 15;19(18):5192-201. doi: 10.1158/1078-0432.CCR-13-0776. Epub 2013 Jul 25.
PMID: 23888069
citation: Park MS, Ravi V, Conley A, Patel SR, Trent JC, Lev DC, Lazar AJ, Wang WL, Benjamin RS, Araujo DM. The role of chemotherapy in advanced solitary fibrous tumors: a retrospective analysis. Clin Sarcoma Res. 2013 May 11;3(1):7. doi: 10.1186/2045-3329-3-7.
PMID: 23663788
citation: Chaigneau L, Kalbacher E, Thiery-Vuillemin A, Fagnoni-Legat C, Isambert N, Aherfi L, Pauchot J, Delroeux D, Servagi-Vernat S, Mansi L, Pivot X. Efficacy of trabectedin in metastatic solitary fibrous tumor. Rare Tumors. 2011 Jul 11;3(3):e29. doi: 10.4081/rt.2011.e29. Epub 2011 Jul 18.
PMID: 22066036
citation: Khalifa J, Ouali M, Chaltiel L, Le Guellec S, Le Cesne A, Blay JY, Cousin P, Chaigneau L, Bompas E, Piperno-Neumann S, Bui-Nguyen B, Rios M, Delord JP, Penel N, Chevreau C. Efficacy of trabectedin in malignant solitary fibrous tumors: a retrospective analysis from the French Sarcoma Group. BMC Cancer. 2015 Oct 15;15:700. doi: 10.1186/s12885-015-1697-8.
PMID: 26472661
citation: Domont J, Massard C, Lassau N, Armand JP, Le Cesne A, Soria JC. Hemangiopericytoma and antiangiogenic therapy: clinical benefit of antiangiogenic therapy (sorafenib and sunitinib) in relapsed malignant haemangioperyctoma /solitary fibrous tumour. Invest New Drugs. 2010 Apr;28(2):199-202. doi: 10.1007/s10637-009-9249-1. Epub 2009 Apr 8. No abstract available.
PMID: 19352594
citation: Park MS, Patel SR, Ludwig JA, Trent JC, Conrad CA, Lazar AJ, Wang WL, Boonsirikamchai P, Choi H, Wang X, Benjamin RS, Araujo DM. Activity of temozolomide and bevacizumab in the treatment of locally advanced, recurrent, and metastatic hemangiopericytoma and malignant solitary fibrous tumor. Cancer. 2011 Nov 1;117(21):4939-47. doi: 10.1002/cncr.26098. Epub 2011 Apr 8.
PMID: 21480200
citation: Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.
PMID: 24005614
citation: Stacchiotti S, Tortoreto M, Baldi GG, Grignani G, Toss A, Badalamenti G, Cominetti D, Morosi C, Dei Tos AP, Festinese F, Fumagalli E, Provenzano S, Gronchi A, Pennacchioli E, Negri T, Dagrada GP, Spagnuolo RD, Pilotti S, Casali PG, Zaffaroni N. Preclinical and clinical evidence of activity of pazopanib in solitary fibrous tumour. Eur J Cancer. 2014 Nov;50(17):3021-8. doi: 10.1016/j.ejca.2014.09.004. Epub 2014 Sep 27.
PMID: 25269954
citation: Martin-Broto J, Pousa AL, de Las Penas R, Garcia Del Muro X, Gutierrez A, Martinez-Trufero J, Cruz J, Alvarez R, Cubedo R, Redondo A, Maurel J, Carrasco JA, Lopez-Martin JA, Sala A, Meana JA, Ramos R, Martinez-Serra J, Lopez-Guerrero JA, Sevilla I, Balana C, Vaz A, De Juan A, Alemany R, Poveda A. Randomized Phase II Study of Trabectedin and Doxorubicin Compared With Doxorubicin Alone as First-Line Treatment in Patients With Advanced Soft Tissue Sarcomas: A Spanish Group for Research on Sarcoma Study. J Clin Oncol. 2016 Jul 1;34(19):2294-302. doi: 10.1200/JCO.2015.65.3329. Epub 2016 May 16.
PMID: 27185843
responsible party type: Sponsor
mesh term: Solitary Fibrous Tumors
mesh term: Hemangiopericytoma
mesh term: Neoplasms, Fibrous Tissue
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Dacarbazine
mesh term: Trabectedin
sharing ipd: No