<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/NCT03815474</url>
  </required_header>
  <id_info>
    <org_study_id>KY2018012</org_study_id>
    <nct_id>NCT03815474</nct_id>
  </id_info>
  <brief_title>Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients</brief_title>
  <acronym>ALTER-S005</acronym>
  <official_title>Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients: a One-arm, Multi-center, Prospective Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liaoning Tumor Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalian Municipal Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daqing Oil Field Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liaoning Tumor Hospital &amp; Institute</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>
      Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the&#xD;
      angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR),&#xD;
      Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and&#xD;
      tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line&#xD;
      therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in&#xD;
      clinical trials (ALTER-0203).Therefore , this study evaluates the safety and efficacy of&#xD;
      anlotinib plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is planned to be carried out in Liaoning, Jilin and Harbin provinces regional&#xD;
      multi-center. 47 cases are preliminarily expected to be included. The study started in&#xD;
      January 2019 and ended in December 2019. It is expected that the trial will end in December&#xD;
      2020. This study is a phase 2 study evaluating the safety and efficacy anlotinib and plus&#xD;
      epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .&#xD;
&#xD;
      All those participants need to sign informed consent forms for data collection and use for&#xD;
      research purpose before inclusion .Those participants who were not treated with&#xD;
      anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months&#xD;
      should be enrolled.&#xD;
&#xD;
      47 subjects with metastatic or advanced soft tissue sarcoma will receive epirubicin at&#xD;
      30mg/m2/day（day1-2 IV）, ifosfamide at 1.8g/m2/day (day1-5 IV) anlotinib at a dose of 12 mg&#xD;
      once daily (day8-21 PO). After 6 treatment cycles,those participants will receive anlotinib&#xD;
      at a dose of 12 mg once daily (day8-21 PO) in 21-day cycles until disease progression&#xD;
      (defined by RECIST version 1.1) ot unacceptable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progress free survival</measure>
    <time_frame>Until Progressive Disease(PD) or death(up to 24 months)</time_frame>
    <description>Progress free survival (PFS) defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From randomization until death (up to 24 months)</time_frame>
    <description>Overall Survival (OS) is defined as the time until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>Each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
    <description>Objective Response Rate (ORR) is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>Each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
    <description>Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety(Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety)</measure>
    <time_frame>Each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
    <description>Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">47</enrollment>
  <condition>Sarcoma, Soft Tissue</condition>
  <arm_group>
    <arm_group_label>anlotinib &amp; epirubicin&amp; ifosfamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>interventions:Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anlotinib</intervention_name>
    <description>Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease</description>
    <arm_group_label>anlotinib &amp; epirubicin&amp; ifosfamide</arm_group_label>
    <other_name>epirubicin ifosfamide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed the informed consent form prior to patient entry;&#xD;
&#xD;
          -  ≥ 18 years of age , regardless of gender；ECOG :0-1;Expected Survival Time: Over 3&#xD;
             months;&#xD;
&#xD;
          -  Histologically confirmed diagnosis of un-resectable or recurrent metastatic soft&#xD;
             tissue sarcoma, such as: leiomyosarcoma, synovial sarcoma, undifferentiated&#xD;
             pleomorphic sarcoma, liposarcoma , angiosarcoma and other sarcomas. The following&#xD;
             histologies are excluded: alveolar Soft tissue sarcoma, rhabdomyosarcoma,&#xD;
             chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor, humeral cutaneous&#xD;
             fibrosarcoma, Ewing sarcoma/primary neuroectodermal tumor, inflammatory&#xD;
             myofibroblastic sarcoma and malignant mesothelioma.&#xD;
&#xD;
          -  Patients who were not treated with anthracyclines or other tyrosinase inhibitors or&#xD;
             angiostatins within the first 6 months should be enrolled.&#xD;
&#xD;
          -  Evaluable disease by imaging or physical exam or measurable disease defined as at&#xD;
             least one lesion that can be accurately measured according to RECIST version 1.1.&#xD;
&#xD;
          -  normal main organs function as defined below: Hemoglobin (Hb) ≥ 80g / L, Neutrophils&#xD;
             (ANC) ≥ 1.5 × 109 / L, Platelet count (PLT) ≥ 80 × 109 / L, Serum creatinine (Cr) ≤&#xD;
             1.5 × normal upper limit (ULN) or creatinine clearance (CCr) ≥ 60ml / min, Blood urea&#xD;
             nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Total bilirubin (TB) ≤ 1.5 × ULN;&#xD;
             Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; If&#xD;
             accompanied by liver metastases, ALT and AST ≤ 5 × ULN Albumin (ALB) ≥ 25 g/L. Doppler&#xD;
             ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit&#xD;
             (50%)&#xD;
&#xD;
          -  Women of childbearing potential should agree to use and utilize an adequate method of&#xD;
             contraception (such as intrauterine device，contraceptive and condom) throughout&#xD;
             treatment and for at least 6 months after study is stopped；the result of serum or&#xD;
             urine pregnancy test should be negative within 7 days prior to study enrollment，and&#xD;
             the patients required to be non-lactating；Man participants should agree to use and&#xD;
             utilize an adequate method of contraception throughout treatment and for at least 6&#xD;
             months after study is stopped.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with any VEGFR tyrosine kinase inhibitor(such as sunitinib, sorafenib,&#xD;
             bevacizumab, imatinib, famitinib, apatinib, regorafenib and other drugs).&#xD;
&#xD;
          -  Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction&#xD;
             inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or&#xD;
             during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to&#xD;
             enrollment.&#xD;
&#xD;
          -  A history of other malignancy ≤ 3 years previous&#xD;
&#xD;
          -  Known brain metastases.&#xD;
&#xD;
          -  The investigator judged that during the follow-up study, the tumor is very likely to&#xD;
             invade the important blood vessels and cause fatal hemorrhage, or the formation of&#xD;
             tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins,&#xD;
             superior vena cava);&#xD;
&#xD;
          -  The investigator judged that the presence of distinct pulmonary cavitary or necrotic&#xD;
             tumors;&#xD;
&#xD;
          -  Serosal effusion with clinical symptoms requiring surgical management (including&#xD;
             hydrothorax and ascites pericardial effusion)&#xD;
&#xD;
          -  with any severe and/or uncontrolled disease, including:1)Uncontrollable hypertension&#xD;
             (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite&#xD;
             optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or&#xD;
             myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450&#xD;
             ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association (&#xD;
             NYHA) rating).3)Poor control of diabetes (fasting blood glucose &gt; 10mmol / L).4)Active&#xD;
             or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC&#xD;
             AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B:&#xD;
             HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C&#xD;
             virus(HCV) RNA-positive and abnormal liver function), or active infection requiring&#xD;
             antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs,&#xD;
             antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++,&#xD;
             or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment&#xD;
&#xD;
          -  Abnormal coagulation (INR &gt; 1.5 or prothrombin time (PT) &gt; ULN + 4 seconds or&#xD;
             activated partial thromboplastin time(APTT) &gt; 1.5 ULN), with bleeding tendency or&#xD;
             undergoing thrombolytic or anticoagulant therapy.&#xD;
&#xD;
          -  Patients treated with anticoagulants or vitamin K antagonists such as warfarin,&#xD;
             heparin.&#xD;
&#xD;
          -  significant coughing blood in the 2 months before enrollment, or daily hemoptysis of&#xD;
             2.5ml or more.&#xD;
&#xD;
          -  history of psychotropic substance abuse who are unable to quit or have a mental&#xD;
             disorder.&#xD;
&#xD;
          -  Tendencies of hereditary or acquired hemorrhagic and thrombotic (such as hemophilia&#xD;
             patients, coagulopathy, thrombocytopenia, hypersplenism, etc.)&#xD;
&#xD;
          -  Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone&#xD;
             major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes&#xD;
             which the degree is bigger than CTCAE 3 grade within 4 weeks prior to enrollment.&#xD;
&#xD;
          -  Active period digestive ulcers.&#xD;
&#xD;
          -  Cavity sinus or perforation occurred within 6 months.&#xD;
&#xD;
          -  Participated in other anti-tumor clinical trials within 4 weeks.&#xD;
&#xD;
          -  Received a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole, erythromycin,&#xD;
             and clarithromycin) within 7 days, or received a potent CYP3A4 inducer within 12 days&#xD;
             prior to the study (eg. catarrh Treatment with imipramine, rifampicin and&#xD;
             phenobarbital).&#xD;
&#xD;
          -  Allergic reactions, hypersensitivity reactions or intolerance to anlotinib&#xD;
             hydrochloride or its excipients.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  The investigator believes that there are any conditions that may damage the subject or&#xD;
             result in the subject not being able to meet or perform the research request.&#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>Li Shenglong, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Project sponsor of Liaoning Province Tumor Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Shenglong, master</last_name>
    <phone>18900918348</phone>
    <email>lishenglong@cancerhosp-ln-cmu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Liaoning Province Tumor Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Shenglong, master</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.</citation>
    <PMID>26378637</PMID>
  </results_reference>
  <results_reference>
    <citation>Spannuth WA, Sood AK, Coleman RL. Angiogenesis as a strategic target for ovarian cancer therapy. Nat Clin Pract Oncol. 2008 Apr;5(4):194-204. doi: 10.1038/ncponc1051. Epub 2008 Feb 12.</citation>
    <PMID>18268546</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>July 7, 2019</last_update_submitted>
  <last_update_submitted_qc>July 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2019</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epirubicin</mesh_term>
    <mesh_term>Ifosfamide</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/NCT03815474
org study id: KY2018012
nct id: NCT03815474
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Anlotinib is a multi-target receptor tyrosine kinase inhibitor. It can inhibit the
      angiogenesis related kinase, such as Vascular Endothelial Growth Factor Receptor (VEGFR),
      Fibroblast Growth Factor Receptor(FGFR), Platelet-Derived Growth Factor Receptor(PDGFR), and
      tumor cell proliferation related kinase c-Kit kinase. Anlotinib is an efficient second line
      therapeutic agent in treatment for metastatic soft tissue sarcoma which has been approved in
      clinical trials (ALTER-0203).Therefore , this study evaluates the safety and efficacy of
      anlotinib plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma
      .
This study is planned to be carried out in Liaoning, Jilin and Harbin provinces regional
      multi-center. 47 cases are preliminarily expected to be included. The study started in
      January 2019 and ended in December 2019. It is expected that the trial will end in December
      2020. This study is a phase 2 study evaluating the safety and efficacy anlotinib and plus
      epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .

      All those participants need to sign informed consent forms for data collection and use for
      research purpose before inclusion .Those participants who were not treated with
      anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months
      should be enrolled.

      47 subjects with metastatic or advanced soft tissue sarcoma will receive epirubicin at
      30mg/m2/day（day1-2 IV）, ifosfamide at 1.8g/m2/day (day1-5 IV) anlotinib at a dose of 12 mg
      once daily (day8-21 PO). After 6 treatment cycles,those participants will receive anlotinib
      at a dose of 12 mg once daily (day8-21 PO) in 21-day cycles until disease progression
      (defined by RECIST version 1.1) ot unacceptable toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress free survival
time frame: Until Progressive Disease(PD) or death(up to 24 months)
description: Progress free survival (PFS) defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
measure: Overall Survival
time frame: From randomization until death (up to 24 months)
description: Overall Survival (OS) is defined as the time until death due to any cause.
measure: Objective Response Rate
time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
description: Objective Response Rate (ORR) is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
measure: Disease Control Rate
time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
description: Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
measure: Safety(Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety)
time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
description: Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety.
arm group label: anlotinib & epirubicin& ifosfamide
arm group type: Experimental
description: interventions:Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
intervention type: Drug
intervention name: anlotinib
description: Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
arm group label: anlotinib & epirubicin& ifosfamide
other name: epirubicin ifosfamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Li Shenglong, master
role: Principal Investigator
affiliation: Project sponsor of Liaoning Province Tumor Hospital
last name: Li Shenglong, master
phone: 18900918348
email: lishenglong@cancerhosp-ln-cmu.com
facility: 
status: Recruiting
contact: 
country: China
citation: Chawla SP, Papai Z, Mukhametshina G, Sankhala K, Vasylyev L, Fedenko A, Khamly K, Ganjoo K, Nagarkar R, Wieland S, Levitt DJ. First-Line Aldoxorubicin vs Doxorubicin in Metastatic or Locally Advanced Unresectable Soft-Tissue Sarcoma: A Phase 2b Randomized Clinical Trial. JAMA Oncol. 2015 Dec;1(9):1272-80. doi: 10.1001/jamaoncol.2015.3101.
PMID: 26378637
citation: Spannuth WA, Sood AK, Coleman RL. Angiogenesis as a strategic target for ovarian cancer therapy. Nat Clin Pract Oncol. 2008 Apr;5(4):194-204. doi: 10.1038/ncponc1051. Epub 2008 Feb 12.
PMID: 18268546
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Epirubicin
mesh term: Ifosfamide
sharing ipd: No