<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/NCT03816475</url>
  </required_header>
  <id_info>
    <org_study_id>LIPOMYX1</org_study_id>
    <nct_id>NCT03816475</nct_id>
  </id_info>
  <brief_title>Hypofractionated Radiotherapy in Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall (LIPO-MYX Trial)</brief_title>
  <acronym>LIPOMYX</acronym>
  <official_title>Hypofractionated 5x5 Gy Radiotherapy With Prolonged Gap Before Surgery in Preoperative Treatment of Patients With Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Sklodowska-Curie National Research Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maria Sklodowska-Curie National Research Institute of Oncology</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>
      After a screening, which consists of pathology confirmation, physical examination, magnetic&#xD;
      resonance imaging (MRI), body computed tomography (CT) scan, blood tests, and case analysis&#xD;
      on Multidisciplinary Team (MDT) meeting, patient will be irradiated 5x5 Gy and after&#xD;
      radiotherapy and then referred for surgery 6-8 weeks after the radiotherapy completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myxoid liposarcoma has been reported to be more radiosensitive compared with other soft&#xD;
      tissue sarcomas (STS). Response to preoperative treatment involves in decrease in tumor size,&#xD;
      a large percentage in tumor necrosis (which according to some reports has a beneficial effect&#xD;
      on the reduction of local recurrence rates) and also among other in a change in vasculature&#xD;
      of the tissue.&#xD;
&#xD;
      Hypofractionation represents a variation of radiotherapy fractionation in which the total&#xD;
      dose is divided into fewer fractions with an increased fraction dose. Such treatment may lead&#xD;
      to additional biological effects when compared to conventionally fractionated radiotherapy&#xD;
      (eg. vascular damage, increased immunogenicity, and antigenicity). The main advantages of&#xD;
      hypofractionation are those related to the decreased overall treatment time what is more&#xD;
      convenient for both patients and physicians, increased compliance and makes the treatment&#xD;
      more cost-effective. Intriguing, such an approach may provide an additional benefit when&#xD;
      treating non-radiosensitive tumors with a low alpha/beta ratio (eg. sarcomas).&#xD;
&#xD;
      The use of preoperative hypofractionated radiotherapy 5x5 Gy for five consecutive days, and&#xD;
      then immediate surgery in patients with locally advanced soft tissue sarcomas showed in a&#xD;
      published study a good local control rate, with a favorable amount of late toxicities. In&#xD;
      this patient population, there were 22 patients with primary myxoid liposarcoma and the local&#xD;
      control rate in this group was 86%.&#xD;
&#xD;
      In the proposed study we plan to increase the gap between the end of radiotherapy and surgery&#xD;
      to commonly applied five weeks to better assess the changes occurring in the tumor after&#xD;
      treatment and to evaluate the impact of longer treatment interval on reducing the proportion&#xD;
      of early complications of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 24, 2015</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Wound complication rate</measure>
    <time_frame>6 months</time_frame>
    <description>Wound complication rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of tumor necrosis</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control rate</measure>
    <time_frame>60 months</time_frame>
    <description>Local control rate at 5 years</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Myxoid Liposarcoma</condition>
  <arm_group>
    <arm_group_label>Hypofractionated radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5x5 Gy radiotherapy and delayed surgery (after 6-8 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionated radiotherapy</intervention_name>
    <description>Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance.</description>
    <arm_group_label>Hypofractionated radiotherapy</arm_group_label>
    <other_name>5x5 Gy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2;&#xD;
&#xD;
          -  pathologically confirmed diagnosis of localized, potentially resectable myxoid&#xD;
             liposarcoma;&#xD;
&#xD;
          -  primary tumor without previous treatment;&#xD;
&#xD;
          -  extremity or trunk wall localization of the tumor;&#xD;
&#xD;
          -  eligibility for limb-sparing surgery;&#xD;
&#xD;
          -  &gt;= 5cm in the longest diameter at imaging staging (MRI);&#xD;
&#xD;
          -  adequate hematologic, liver, and renal function;&#xD;
&#xD;
          -  women of childbearing potential must have a negative pregnancy test on the day of&#xD;
             registration for study;&#xD;
&#xD;
          -  female subjects who are breastfeeding should discontinue nursing prior to the first&#xD;
             day of study treatment and during the whole radiotherapy treatment;&#xD;
&#xD;
          -  no co-existing malignancy within the last 2 years except for adequately treated basal&#xD;
             cell carcinoma of the skin or carcinoma in situ of the cervix;&#xD;
&#xD;
          -  the absence of any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule; those&#xD;
             conditions should be discussed with the patient before randomization in the trial;&#xD;
&#xD;
          -  before patient randomization, written informed consent must be given according to&#xD;
             ICH/GCP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of radiation to the affected volume;&#xD;
&#xD;
          -  previous or planned neoadjuvant chemotherapy;&#xD;
&#xD;
          -  contraindications to radiotherapy, or surgery;&#xD;
&#xD;
          -  metastatic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maria Sklodowska-Curie Institute - Oncology Center</name>
      <address>
        <city>Warsaw</city>
        <state>Mazovian</state>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Kosela-Paterczyk H, Szacht M, Morysinski T, Lugowska I, Dziewirski W, Falkowski S, Zdzienicki M, Pienkowski A, Szamotulska K, Switaj T, Rutkowski P. Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Eur J Surg Oncol. 2014 Dec;40(12):1641-7. doi: 10.1016/j.ejso.2014.05.016. Epub 2014 Sep 20.</citation>
    <PMID>25282099</PMID>
  </reference>
  <reference>
    <citation>Chung PW, Deheshi BM, Ferguson PC, Wunder JS, Griffin AM, Catton CN, Bell RS, White LM, Kandel RA, O'Sullivan B. Radiosensitivity translates into excellent local control in extremity myxoid liposarcoma: a comparison with other soft tissue sarcomas. Cancer. 2009 Jul 15;115(14):3254-61. doi: 10.1002/cncr.24375.</citation>
    <PMID>19472403</PMID>
  </reference>
  <reference>
    <citation>Messiou C, Bonvalot S, Gronchi A, Vanel D, Meyer M, Robinson P, Morosi C, Bloem JL, Terrier PH, Lazar A, Le Pechoux C, Wardelman E, Winfield JM, Boulet B, Bovee J, Haas RL. Evaluation of response after pre-operative radiotherapy in soft tissue sarcomas; the European Organisation for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG) and Imaging Group recommendations for radiological examination and reporting with an emphasis on magnetic resonance imaging. Eur J Cancer. 2016 Mar;56:37-44. doi: 10.1016/j.ejca.2015.12.008. Epub 2016 Jan 20.</citation>
    <PMID>26802529</PMID>
  </reference>
  <reference>
    <citation>Kosela-Paterczyk H, Szumera-Cieckiewicz A, Szacht M, Haas R, Morysinski T, Dziewirski W, Prochorec-Sobieszek M, Rutkowski P. Efficacy of neoadjuvant hypofractionated radiotherapy in patients with locally advanced myxoid liposarcoma. Eur J Surg Oncol. 2016 Jun;42(6):891-8. doi: 10.1016/j.ejso.2016.02.258. Epub 2016 Mar 18.</citation>
    <PMID>27026512</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dose Hypofractionation</keyword>
  <keyword>Neoadjuvant Therapy</keyword>
  <keyword>Sarcoma</keyword>
  <keyword>Dose Fractionation</keyword>
  <keyword>Dose-Response Relationship</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liposarcoma</mesh_term>
    <mesh_term>Liposarcoma, Myxoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03816475
org study id: LIPOMYX1
nct id: NCT03816475
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After a screening, which consists of pathology confirmation, physical examination, magnetic
      resonance imaging (MRI), body computed tomography (CT) scan, blood tests, and case analysis
      on Multidisciplinary Team (MDT) meeting, patient will be irradiated 5x5 Gy and after
      radiotherapy and then referred for surgery 6-8 weeks after the radiotherapy completion.
Myxoid liposarcoma has been reported to be more radiosensitive compared with other soft
      tissue sarcomas (STS). Response to preoperative treatment involves in decrease in tumor size,
      a large percentage in tumor necrosis (which according to some reports has a beneficial effect
      on the reduction of local recurrence rates) and also among other in a change in vasculature
      of the tissue.

      Hypofractionation represents a variation of radiotherapy fractionation in which the total
      dose is divided into fewer fractions with an increased fraction dose. Such treatment may lead
      to additional biological effects when compared to conventionally fractionated radiotherapy
      (eg. vascular damage, increased immunogenicity, and antigenicity). The main advantages of
      hypofractionation are those related to the decreased overall treatment time what is more
      convenient for both patients and physicians, increased compliance and makes the treatment
      more cost-effective. Intriguing, such an approach may provide an additional benefit when
      treating non-radiosensitive tumors with a low alpha/beta ratio (eg. sarcomas).

      The use of preoperative hypofractionated radiotherapy 5x5 Gy for five consecutive days, and
      then immediate surgery in patients with locally advanced soft tissue sarcomas showed in a
      published study a good local control rate, with a favorable amount of late toxicities. In
      this patient population, there were 22 patients with primary myxoid liposarcoma and the local
      control rate in this group was 86%.

      In the proposed study we plan to increase the gap between the end of radiotherapy and surgery
      to commonly applied five weeks to better assess the changes occurring in the tumor after
      treatment and to evaluate the impact of longer treatment interval on reducing the proportion
      of early complications of treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wound complication rate
time frame: 6 months
description: Wound complication rate
measure: Percentage of tumor necrosis
time frame: 2 months
measure: Local control rate
time frame: 60 months
description: Local control rate at 5 years
arm group label: Hypofractionated radiotherapy
arm group type: Experimental
description: 5x5 Gy radiotherapy and delayed surgery (after 6-8 weeks)
intervention type: Radiation
intervention name: Hypofractionated radiotherapy
description: Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance.
arm group label: Hypofractionated radiotherapy
other name: 5x5 Gy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
citation: Kosela-Paterczyk H, Szacht M, Morysinski T, Lugowska I, Dziewirski W, Falkowski S, Zdzienicki M, Pienkowski A, Szamotulska K, Switaj T, Rutkowski P. Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. Eur J Surg Oncol. 2014 Dec;40(12):1641-7. doi: 10.1016/j.ejso.2014.05.016. Epub 2014 Sep 20.
PMID: 25282099
citation: Chung PW, Deheshi BM, Ferguson PC, Wunder JS, Griffin AM, Catton CN, Bell RS, White LM, Kandel RA, O'Sullivan B. Radiosensitivity translates into excellent local control in extremity myxoid liposarcoma: a comparison with other soft tissue sarcomas. Cancer. 2009 Jul 15;115(14):3254-61. doi: 10.1002/cncr.24375.
PMID: 19472403
citation: Messiou C, Bonvalot S, Gronchi A, Vanel D, Meyer M, Robinson P, Morosi C, Bloem JL, Terrier PH, Lazar A, Le Pechoux C, Wardelman E, Winfield JM, Boulet B, Bovee J, Haas RL. Evaluation of response after pre-operative radiotherapy in soft tissue sarcomas; the European Organisation for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG) and Imaging Group recommendations for radiological examination and reporting with an emphasis on magnetic resonance imaging. Eur J Cancer. 2016 Mar;56:37-44. doi: 10.1016/j.ejca.2015.12.008. Epub 2016 Jan 20.
PMID: 26802529
citation: Kosela-Paterczyk H, Szumera-Cieckiewicz A, Szacht M, Haas R, Morysinski T, Dziewirski W, Prochorec-Sobieszek M, Rutkowski P. Efficacy of neoadjuvant hypofractionated radiotherapy in patients with locally advanced myxoid liposarcoma. Eur J Surg Oncol. 2016 Jun;42(6):891-8. doi: 10.1016/j.ejso.2016.02.258. Epub 2016 Mar 18.
PMID: 27026512
responsible party type: Sponsor
mesh term: Liposarcoma
mesh term: Liposarcoma, Myxoid
sharing ipd: Undecided