<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/NCT03773510</url>
  </required_header>
  <id_info>
    <org_study_id>ISG TRADITIONS</org_study_id>
    <nct_id>NCT03773510</nct_id>
  </id_info>
  <brief_title>Study on Leiomyosarcoma, Liposarcomas and Synovial Sarcoma With Trabectedin</brief_title>
  <acronym>TRADITIONS</acronym>
  <official_title>Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Italian Sarcoma Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PharmaMar</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Italian Sarcoma Group</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>
      Two arm, randomized, open-label study, to determine the best time to secondary resistance&#xD;
      between responding patients who discontinue treatment and resumed Trabectedin at the time of&#xD;
      progression versus patients who continued treatment until progression. T&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an Italian, multicenter, randomized, open-label , two arm, study, to determine the&#xD;
      best time to secondary resistance between responding patients who discontinue treatment and&#xD;
      resumed Trabectedin at the time of progression versus patients who continued treatment until&#xD;
      progression. The aim is to evaluate the best clinical practice for responding patients as&#xD;
      Trabectedin has an acceptable safety profile with no evidence of cumulative toxicity.&#xD;
&#xD;
      After signing informed consent and being assessed for eligibility criteria , eligible&#xD;
      patients will start the trabectedin treatment.&#xD;
&#xD;
      All the patients who will complete 6 cycles of treatment without disease progression will be&#xD;
      be randomized to continue Trabectedin versus &quot;treatment interruption&quot; followed by&#xD;
      re-challenge at progression. Patients randomized to discontinue treatment will be candidate&#xD;
      to other 6 cycles of treatment and if they do not progress, to another interruption. The&#xD;
      treatment will be resumed again at progression for other 6 cycles and this scheme of&#xD;
      treatment will be proposed until progression under Trabectedin.&#xD;
&#xD;
      The study will be conducted in Italy in approximately 12 centers, in order to recruit 330&#xD;
      evaluable patients over a 4 year period. The follow-up will last approximately 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not approved by the coordinating Ethical Committee&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 28, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, open-label , two arm study All the patients who will complete 6 cycles of treatment without disease progression will be be randomized to continue Trabectedin versus &quot;treatment interruption&quot; followed by re-challenge at progression. Patients randomized to discontinue treatment will be candidate to other 6 cycles of treatment and if they do not progress, to another interruption. The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under Trabectedin.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time secondary resistance to Trabectedin</measure>
    <time_frame>Week 18</time_frame>
    <description>Time secondary resistance to Trabectedin is the time from the first trabectedin dose to progression not amenable to treatment with Trabectedin, or death, whichever occurs first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>month 6,month 12, month 18, month 24, months 30, month 36, month 42, month 48, month 54, month 60</time_frame>
    <description>Overall Survival is the time from the first trabectedin dose to death for any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse event</measure>
    <time_frame>Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81</time_frame>
    <description>Adverse events are evaluate from the first trabectedin dose throughout the study according to CTCAE 5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81</time_frame>
    <description>Time from the first trabectedin dose to time of onset of progression disease</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Leiomyosarcoma</condition>
  <condition>Liposarcoma</condition>
  <condition>Synovial Sarcoma</condition>
  <arm_group>
    <arm_group_label>Trabectedin continuation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All the patients who will complete 6 cycles of trabectedin without disease progression, will continue trabectedin until progressive disease, unacceptable toxicity, patient or investigator decision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trabectedin discontinuation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the patients who will complete 6 cycles of trabectedin without disease progression , will discontinue trabectedin.&#xD;
The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trabectedin discontinuation</intervention_name>
    <description>Patients who did not progressed after 6 cycles of trabectedin will stop the treatment and resume drug in case of progression for other 6 cycles.&#xD;
The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.</description>
    <arm_group_label>Trabectedin discontinuation</arm_group_label>
    <other_name>Treatment discontinuation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trabectedin continuation</intervention_name>
    <description>Patients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity</description>
    <arm_group_label>Trabectedin continuation</arm_group_label>
    <other_name>Treatment continuation</other_name>
  </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 and must have been willing to give written informed consent and any&#xD;
             locally required authorization before any study-specific procedures, including&#xD;
             screening evaluations, sampling, and analyses&#xD;
&#xD;
          2. Diagnosis of well differentiated/dedifferentiated liposarcoma, mixoid round cell&#xD;
             liposarcoma, leiomyosarcoma or synovial sarcoma&#xD;
&#xD;
          3. Persistent or locally relapsed and/or metastatic disease&#xD;
&#xD;
          4. Pathology specimens available for centralized review (central review is not mandatory&#xD;
             prior to start the treatment, but within a month from screening, tumor sample must be&#xD;
             sent to central pathology reviewer for a retrospective diagnosis confirmation).&#xD;
&#xD;
          5. Age ≥ 18 years&#xD;
&#xD;
          6. Adequate bone marrow function&#xD;
&#xD;
          7. Adequate organ function,&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group Performance Status ≤ 2&#xD;
&#xD;
          9. One or more previous systemic treatments with anthracyclines with or without&#xD;
             ifosfamide (unless one or both are clinically contraindicated)&#xD;
&#xD;
         10. Measurable disease. Patient who received radiotherapy within 3 weeks form the&#xD;
             treatment start, can be included as long there is a measurable lesion outside of the&#xD;
             irradiation field&#xD;
&#xD;
         11. A minimum of 3 weeks since any previous chemotherapy treatment&#xD;
&#xD;
         12. Recovery from toxic effects of prior therapies to (Grade 1 or lower)&#xD;
&#xD;
         13. 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;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or breast-feeding women&#xD;
&#xD;
          2. Prior exposure to Trabectedin&#xD;
&#xD;
          3. Peripheral neuropathy, Grade 2 or higher&#xD;
&#xD;
          4. History of other malignancies (except basal cell carcinoma or cervical carcinoma in&#xD;
             situ, adequately treated), unless in remission from 5 years or more and judged of&#xD;
             negligible potential of relapse&#xD;
&#xD;
          5. Known central nervous system metastases&#xD;
&#xD;
          6. Active viral hepatitis or chronic liver disease&#xD;
&#xD;
          7. Unstable cardiac condition, including congestive heart failure or angina pectoris,&#xD;
             myocardial infarction within six months before enrollment, uncontrolled arterial&#xD;
             hypertension or arrhythmia&#xD;
&#xD;
          8. Active major infection&#xD;
&#xD;
          9. Previous treatment with any other investigational or not investigational agents within&#xD;
             14 days of first day of study drug dosing&#xD;
&#xD;
         10. Known history of human immunodeficiency virus infection&#xD;
&#xD;
         11. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in&#xD;
             the formulation of the study drugs&#xD;
&#xD;
         12. Other serious concomitant illnesses or any condition that may interfere with the&#xD;
             subject's participation in the study or evaluation of the study results&#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>Roberta Sanfilippo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS INT di Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>A.O. SS Antonio e Biagio e Cesare Arrigo</name>
      <address>
        <city>Alessandria</city>
        <state>AL</state>
        <zip>15100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST</name>
      <address>
        <city>Meldola</city>
        <state>FC</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>MI</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico di Aviano</name>
      <address>
        <city>Aviano</city>
        <state>PD</state>
        <zip>33081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Biomedico</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione del Piemonte per l'Oncologia IRCC Candiolo</name>
      <address>
        <city>Candiolo</city>
        <state>Torino</state>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Gradenigo</name>
      <address>
        <city>Torino</city>
        <state>TO</state>
        <zip>10153</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda ospedaliero Universitaria Careggi di Firenze</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS INT Milano</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Federico II</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Istituto Oncologico Veneto (Iov)</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Giaccone</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituti Fisioterapici Ospitalieri di Roma</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther. 2010 Aug;9(8):2157-63. doi: 10.1158/1535-7163.MCT-10-0263. Epub 2010 Jul 20.</citation>
    <PMID>20647340</PMID>
  </reference>
  <reference>
    <citation>Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. doi: 10.1200/JCO.2015.62.4734. Epub 2015 Sep 14.</citation>
    <PMID>26371143</PMID>
  </reference>
  <reference>
    <citation>Sanfilippo R, Dileo P, Blay JY, Constantinidou A, Le Cesne A, Benson C, Vizzini L, Contu M, Baldi GG, Dei Tos AP, Casali PG. Trabectedin in advanced synovial sarcomas: a multicenter retrospective study from four European institutions and the Italian Rare Cancer Network. Anticancer Drugs. 2015 Jul;26(6):678-81. doi: 10.1097/CAD.0000000000000228.</citation>
    <PMID>25763543</PMID>
  </reference>
  <reference>
    <citation>Grosso F, Dileo P, Sanfilippo R, Stacchiotti S, Bertulli R, Piovesan C, Jimeno J, D'Incalci M, Gescher A, Casali PG. Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer. 2006 Jul;42(10):1484-90. doi: 10.1016/j.ejca.2006.02.010. Epub 2006 Jun 5.</citation>
    <PMID>16737808</PMID>
  </reference>
  <reference>
    <citation>Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.</citation>
    <PMID>25680558</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>trabectedin</keyword>
  <keyword>soft tissue sarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Leiomyosarcoma</mesh_term>
    <mesh_term>Liposarcoma</mesh_term>
    <mesh_term>Sarcoma, Synovial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03773510
org study id: ISG TRADITIONS
nct id: NCT03773510
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Two arm, randomized, open-label study, to determine the best time to secondary resistance
      between responding patients who discontinue treatment and resumed Trabectedin at the time of
      progression versus patients who continued treatment until progression. T
This is an Italian, multicenter, randomized, open-label , two arm, study, to determine the
      best time to secondary resistance between responding patients who discontinue treatment and
      resumed Trabectedin at the time of progression versus patients who continued treatment until
      progression. The aim is to evaluate the best clinical practice for responding patients as
      Trabectedin has an acceptable safety profile with no evidence of cumulative toxicity.

      After signing informed consent and being assessed for eligibility criteria , eligible
      patients will start the trabectedin treatment.

      All the patients who will complete 6 cycles of treatment without disease progression will be
      be randomized to continue Trabectedin versus "treatment interruption" followed by
      re-challenge at progression. Patients randomized to discontinue treatment will be candidate
      to other 6 cycles of treatment and if they do not progress, to another interruption. The
      treatment will be resumed again at progression for other 6 cycles and this scheme of
      treatment will be proposed until progression under Trabectedin.

      The study will be conducted in Italy in approximately 12 centers, in order to recruit 330
      evaluable patients over a 4 year period. The follow-up will last approximately 3 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, open-label , two arm study All the patients who will complete 6 cycles of treatment without disease progression will be be randomized to continue Trabectedin versus "treatment interruption" followed by re-challenge at progression. Patients randomized to discontinue treatment will be candidate to other 6 cycles of treatment and if they do not progress, to another interruption. The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under Trabectedin.
primary purpose: Treatment
masking: None (Open Label)
measure: Time secondary resistance to Trabectedin
time frame: Week 18
description: Time secondary resistance to Trabectedin is the time from the first trabectedin dose to progression not amenable to treatment with Trabectedin, or death, whichever occurs first
measure: Overall Survival
time frame: month 6,month 12, month 18, month 24, months 30, month 36, month 42, month 48, month 54, month 60
description: Overall Survival is the time from the first trabectedin dose to death for any cause
measure: Incidence of adverse event
time frame: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81
description: Adverse events are evaluate from the first trabectedin dose throughout the study according to CTCAE 5.0
measure: Progression free survival
time frame: Week 9, week 18, week 27, week 36, week 45, week 54, week 63, week 72, week 81
description: Time from the first trabectedin dose to time of onset of progression disease
arm group label: Trabectedin continuation
arm group type: Active Comparator
description: All the patients who will complete 6 cycles of trabectedin without disease progression, will continue trabectedin until progressive disease, unacceptable toxicity, patient or investigator decision
arm group label: Trabectedin discontinuation
arm group type: Experimental
description: All the patients who will complete 6 cycles of trabectedin without disease progression , will discontinue trabectedin.
The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.
intervention type: Drug
intervention name: Trabectedin discontinuation
description: Patients who did not progressed after 6 cycles of trabectedin will stop the treatment and resume drug in case of progression for other 6 cycles.
The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin.
arm group label: Trabectedin discontinuation
other name: Treatment discontinuation
intervention type: Drug
intervention name: Trabectedin continuation
description: Patients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity
arm group label: Trabectedin continuation
other name: Treatment continuation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberta Sanfilippo, MD
role: Principal Investigator
affiliation: Fondazione IRCCS INT di Milano
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
citation: D'Incalci M, Galmarini CM. A review of trabectedin (ET-743): a unique mechanism of action. Mol Cancer Ther. 2010 Aug;9(8):2157-63. doi: 10.1158/1535-7163.MCT-10-0263. Epub 2010 Jul 20.
PMID: 20647340
citation: Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. doi: 10.1200/JCO.2015.62.4734. Epub 2015 Sep 14.
PMID: 26371143
citation: Sanfilippo R, Dileo P, Blay JY, Constantinidou A, Le Cesne A, Benson C, Vizzini L, Contu M, Baldi GG, Dei Tos AP, Casali PG. Trabectedin in advanced synovial sarcomas: a multicenter retrospective study from four European institutions and the Italian Rare Cancer Network. Anticancer Drugs. 2015 Jul;26(6):678-81. doi: 10.1097/CAD.0000000000000228.
PMID: 25763543
citation: Grosso F, Dileo P, Sanfilippo R, Stacchiotti S, Bertulli R, Piovesan C, Jimeno J, D'Incalci M, Gescher A, Casali PG. Steroid premedication markedly reduces liver and bone marrow toxicity of trabectedin in advanced sarcoma. Eur J Cancer. 2006 Jul;42(10):1484-90. doi: 10.1016/j.ejca.2006.02.010. Epub 2006 Jun 5.
PMID: 16737808
citation: Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.
PMID: 25680558
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Leiomyosarcoma
mesh term: Liposarcoma
mesh term: Sarcoma, Synovial
mesh term: Trabectedin
sharing ipd: No