<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/NCT03838718</url>
  </required_header>
  <id_info>
    <org_study_id>201/16</org_study_id>
    <nct_id>NCT03838718</nct_id>
  </id_info>
  <brief_title>REtroperitoneal SArcoma Registry: an International Prospective Initiative</brief_title>
  <acronym>RESAR</acronym>
  <official_title>REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TransAtlantic Retroperitoneal Sarcoma Working Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</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>
      Surgery is currently the only potentially curative treatment modality for localized&#xD;
      retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly&#xD;
      retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective&#xD;
      analysis of high quality data is a top priority.&#xD;
&#xD;
      Primary Objectives of this study are:&#xD;
&#xD;
        -  to prospectively collect standardized clinical data and radiological and pathological&#xD;
           material from primary RPS patients treated with surgery at reference centers.&#xD;
&#xD;
        -  patient outcome will be evaluated in terms of overall survival (OS), disease-free&#xD;
           survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant&#xD;
           metastasis (DM).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  to estimate the efficacy and safety of surgical treatment, including extended surgical&#xD;
           approach to primary RPS;&#xD;
&#xD;
        -  to prospectively evaluate the impact of multimodality therapy, including radiation&#xD;
           therapy and chemotherapy;&#xD;
&#xD;
        -  to identify clinical, radiological and pathological characteristics that may influence&#xD;
           the oncological outcome or may be used as predictors of LR/DM/OS. These may be important&#xD;
           biomarkers of disease;&#xD;
&#xD;
        -  to utilize collected pathological material for research collaborations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retroperitoneal sarcomas (RPS) are rare tumors accounting for 10-15% of all soft tissue&#xD;
      sarcomas (STS). They arise between retroperitoneal organs and among vital structures (ie&#xD;
      major abdominal vessels) in an anatomical compartment that is not readily accessible by&#xD;
      physical examination. Four main histotypes account for about 80% of all cases:&#xD;
      well-differentiated liposarcoma (WDLPS), dedifferentiated liposarcoma (DDLPS), leiomyosarcoma&#xD;
      (LMS) and solitary fibrous tumor (SFT).&#xD;
&#xD;
      Compared to sarcomas at other anatomic sites, RPS are burdened by a higher local recurrence&#xD;
      (LR) rate (50% at 5 years) and a poorer overall survival (OS) rate (50% at 5-years). The&#xD;
      natural history of RPS as a whole group reflects the strong tendency of lipomatous tumors&#xD;
      (WDLPS and DDLPS, which account for about 50% of RPS) to recur locally. Indeed, outcome of&#xD;
      primary RPS is highly related to the histological subtype.&#xD;
&#xD;
      WDLPS are characterized by a relatively lower LR rate, negligible metastatic potential and a&#xD;
      favorable overall survival. These tumors however, still may recur locally even years after&#xD;
      the primary resection. Intermediate grade DDLPS are characterized by a strong tendency to&#xD;
      recur locally and low metastatic potential. High grade DDLPS has a high risk of both local&#xD;
      recurrence and distant metastasis. LMS are usually intermediate or high-grade tumors with a&#xD;
      strong tendency to develop distant metastasis; with an adequate resection, it is relatively&#xD;
      common to obtain a durable local control. Classic SFT usually fare well after surgery, with a&#xD;
      low rate of local recurrence and distant metastasis.&#xD;
&#xD;
      Historically, surgery emerged as the only potentially curative option in the localized&#xD;
      setting. In the last few years there has been lively debate as to how far should a surgeon&#xD;
      resect in order to obtain a margin that could be considerate adequate. This issue is&#xD;
      particularly challenging in this anatomical compartment where widening the surgical margins&#xD;
      means resecting adjacent organs.&#xD;
&#xD;
      Since 2002 an 'extended' surgical approach has been proposed for primary RPS patients. The&#xD;
      concept was that surgical margins could be improved by encompassing the tumor with en-bloc&#xD;
      resection of adjacent organs. The aim was to obtain reduced local recurrence and improved&#xD;
      survival. This approach has proven to be effective. In particular, this surgical approach has&#xD;
      been supported by an experimental model, retrospective comparisons, pathology studies&#xD;
      demonstrating adjacent organ involvement, and reports of high rates of residual tumor at&#xD;
      re-excision after conventional (non-extended) primary surgery. Finally, this approach has&#xD;
      been shown to be safe after both short and long term follow-up.&#xD;
&#xD;
      Radiotherapy is an option for RPS, especially in the preoperative setting, but currently the&#xD;
      best evidence for efficacy comes form retrospective, mainly single-center, small size series.&#xD;
      The results of such studies are controversial and high quality data are lacking. A randomized&#xD;
      prospective study led by EORTC (STRASS) is ongoing but results are not expected for several&#xD;
      years.&#xD;
&#xD;
      The role of chemotherapy in the localized disease is also still under investigation,&#xD;
      especially in high grade tumors. So far, there is no agreement on the optimal treatment&#xD;
      strategy, even within reference centers, regarding the use of both chemo- and radiotherapy.&#xD;
      In the recent years European and North-American centers joined the panel of expert and this&#xD;
      led to the formation of the TransAtlantic Retroperitoneal Sarcoma Working Group (TARPSWG),&#xD;
      which now consists of more than 50 representatives from sarcoma centers from all over the&#xD;
      world.&#xD;
&#xD;
      The aim of this collaboration is to expand the knowledge of the disease and formulate shared,&#xD;
      standardized principles of treatment. A retrospective study has been carried out and recently&#xD;
      published by the group to better define patients' outcome and prognostic factors after&#xD;
      surgical resection of primary tumors. Other retrospective studies have been published&#xD;
      focusing on post-relapse outcome, postsurgical morbidity and local recurrence treatment. This&#xD;
      collaboration has also just recently led to the development of consensus guidelines for the&#xD;
      treatment of primary and recurrent and metastatic RPS.&#xD;
&#xD;
      To take advantage of the group collaboration, TARPSWG promoted a prospective collection of&#xD;
      clinical, radiological and pathologic data for RPS.&#xD;
&#xD;
      This study is aimed to prospectively collect standardized clinical data and radiological and&#xD;
      pathological material from primary RPS patients treated with surgery at reference centers.&#xD;
      Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival&#xD;
      (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      This is a prospective, multicentric observational study under the supervision of TARPSWG&#xD;
      (TransAtlantic Retroperitoneal Sarcoma Working Group) aimed to prospectively collect clinical&#xD;
      data and prospectively store radiological and pathological material from patients affected by&#xD;
      primary RPS treated with surgery.&#xD;
&#xD;
      Patients with a diagnosis of primary RPS who meet the eligibility criteria will be invited to&#xD;
      participate to the current study.&#xD;
&#xD;
      Eligible patients will receive full information on the type of surgery proposed and on the&#xD;
      data and material (radiological and pathological) that will be collected. Eligible and&#xD;
      informed patients who give their consent to participate will be included in the Prospective&#xD;
      Cohort Study (PCS) and will be followed-up prospectively.&#xD;
&#xD;
      A data collection form including patient and tumor-related factors, treatment variables,&#xD;
      follow-up findings, development of and time to local recurrence and status at follow-up has&#xD;
      been constructed and shared among all the participating centers.&#xD;
&#xD;
      Each participating reference center will individually be able to have access to both cross&#xD;
      sectional imaging (CT or MRI images) and pathological material (a representative formalin&#xD;
      block of the tumor). Whenever possible patient identifiers will be removed and patient&#xD;
      confidentiality will be maintained. Any data shared between institutions will be deidentified&#xD;
      and all measures to conceal patient identifiers will be taken.&#xD;
&#xD;
      Each center will be responsible for data-entry and storage of its own patients' data,&#xD;
      radiological examinations and pathological samples. At the time of the analysis each center&#xD;
      is committed to provide the requested updated data to the group.&#xD;
&#xD;
      Follow-up will be based on clinical evaluation and on cross sectional imaging (CT scan of the&#xD;
      thorax and abdomen and/or contrast enhanced MRI of the abdomen) every 4 months for the first&#xD;
      2 years, every 6 months until the 5th year and yearly thereafter.&#xD;
&#xD;
      The overall duration of the project has not been fixed.&#xD;
&#xD;
      Sample size&#xD;
&#xD;
      The number of patients we plan to include in this prospective multicenter study will be 400&#xD;
      patients per year.&#xD;
&#xD;
      STATISTICAL CONSIDERATIONS Continuous variables will be summarized with appropriate summary&#xD;
      statistics such as the mean, median, standard deviation, minimum and maximum. Categorical&#xD;
      variables will be tabulated with frequencies and percentages. We will evaluate OS, DFS, CCI&#xD;
      of DM and LR and correlate this with clinicopathologic factors such as histology, grade, type&#xD;
      of surgery, etc.&#xD;
&#xD;
      DATA COLLECTION Data entry will be performed by every participating center. Data will be&#xD;
      collected in a standardized database, stored by every participating center, and shared with&#xD;
      the group at the time of future studies. Data shared between institutions will be&#xD;
      deidentified and whenever possible all measures to conceal patient identifiers and maintain&#xD;
      patient confidentiality will be taken.&#xD;
&#xD;
      ETHICS It is the responsibility of the investigator to have prospective approval of the trial&#xD;
      protocol, informed consent forms, and other relevant documents, from the IRB/IEC. All&#xD;
      correspondence with the IRB/IEC should be retained in the Investigator File.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Disease-free Survival</measure>
    <time_frame>10 years</time_frame>
    <description>Survival after surgery for primary RPS resection; any disease recurrence, local or distant, will be considered as an event at time of first radiological appearance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>10 years</time_frame>
    <description>Overall Survival computed from date of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crude cumulative incidence of Local recurrence</measure>
    <time_frame>10 years</time_frame>
    <description>CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crude cumulative incidence of Distant metastasis</measure>
    <time_frame>10 years</time_frame>
    <description>CCI of distant metastasis computed from date of surgery, and defined as hepatic recurrence and / or extrabdominal recurrent disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity</measure>
    <time_frame>60 days</time_frame>
    <description>Postsurgical morbidity according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Retroperitoneal Sarcoma</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsies, Surgical specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with a primary RPS amenable to surgical resection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary RPS operated on in the participating center;&#xD;
&#xD;
          -  age&gt;18 years at the time of the first treatment (pediatric patients can not be&#xD;
             included)&#xD;
&#xD;
          -  histological confirmed diagnosis according to the WHO criteria done on biopsy or&#xD;
             surgical specimen by dedicated sarcoma pathologist;&#xD;
&#xD;
          -  radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI)&#xD;
             prior to surgical resection;&#xD;
&#xD;
          -  signed informed consent form;&#xD;
&#xD;
          -  adequate compliance of the patients to the plan of follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18 years;&#xD;
&#xD;
          -  recurrent tumor;&#xD;
&#xD;
          -  benign retroperitoneal tumors;&#xD;
&#xD;
          -  serious psychiatric disease that precludes informed consent or limits compliance;&#xD;
&#xD;
          -  impossibility to ensure adequate follow-up&#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>Alessandro Gronchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Fiore, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alessandro Gronchi, MD</last_name>
    <phone>+39022390</phone>
    <phone_ext>3234</phone_ext>
    <email>alessandro.gronchi@istitutotumori.mi.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marco Fiore, MD</last_name>
    <phone>+392390</phone>
    <phone_ext>2910</phone_ext>
    <email>marco.fiore@istitutotumori.mi.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Southern California (USC)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Tseng, MD</last_name>
      <email>William.Tseng@med.usc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanjay Bagaria, MD</last_name>
      <email>Bagaria.sanjay@mayo.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Mullinax, MD</last_name>
      <email>John.Mullinax@moffitt.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute</name>
      <address>
        <city>Emory</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenneth Cardona, MD</last_name>
      <email>ken.cardona@emory.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital/Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chan Raut, MD</last_name>
      <email>craut@bwh.harvard.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raphael Pollock, MD</last_name>
      <email>Raphael.Pollock@osumc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Center</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Gyorki, MD</last_name>
      <email>david.gyorki@petermac.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maisonneuve-Rosemont Hospital / University of Montreal</name>
      <address>
        <city>Montréal</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mai-Kim Gervais, MD</last_name>
      <email>maikim.gervais@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolyn Nessim, MD</last_name>
      <email>cnessim@toh.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mount Sinai / Princess Margaret</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carol Swallow, MD</last_name>
      <email>Carol.Swallow@sinaihealthsystem.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvie Bonvalot, MD</last_name>
      <email>sylvie.bonvalot@curie.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Medical Center and Medical Faculty Mannheim, University of Heidelberg</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Peter Hohenberger, MD</last_name>
      <email>peter.hohenberger@medma.uni-heidelberg.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ludwig Maximilian University</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Albertsmeier, MD</last_name>
      <email>Markus.Albertsmeier@med.uni-muenchen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alessandro Gronchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marco Fiore, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dario Callegaro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Veneto Institute of Oncology</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Rastrelli, MD</last_name>
      <email>marco.rastrelli@iov.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Borgo Roma</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tommaso Campagnaro, MD</last_name>
      <email>tommaso.campagnaro@aovr.veneto.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sung Jo Kim</last_name>
      <email>kmhyj.kim@samsung.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piotr Rutkowski, MD</last_name>
      <email>piotr.rutkowski@coi.pl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute of Oncology Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marko Novak, MD</last_name>
      <email>mnovak@onko-i.si</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario &quot;Virgen de la Arrixaca&quot;</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Juan Angel Fernandez, MD</last_name>
      <email>jaferher@outlook.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Birmingham (Queen Elizabeth)</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel Ford, MD</last_name>
      <email>Samuel.ford@uhb.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dirk Strauss, MD</last_name>
      <email>Dirk.Strauss@rmh.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.tarpswg.org</url>
    <description>website of Trans-Atlantic Retroperitoneal Sarcoma Working Group</description>
  </link>
  <reference>
    <citation>Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Raut CP. Variability in Patterns of Recurrence After Resection of Primary Retroperitoneal Sarcoma (RPS): A Report on 1007 Patients From the Multi-institutional Collaborative RPS Working Group. Ann Surg. 2016 May;263(5):1002-9. doi: 10.1097/SLA.0000000000001447.</citation>
    <PMID>26727100</PMID>
  </reference>
  <reference>
    <citation>Trans-Atlantic RPS Working Group. Management of primary retroperitoneal sarcoma (RPS) in the adult: a consensus approach from the Trans-Atlantic RPS Working Group. Ann Surg Oncol. 2015 Jan;22(1):256-63. doi: 10.1245/s10434-014-3965-2. Epub 2014 Oct 15.</citation>
    <PMID>25316486</PMID>
  </reference>
  <reference>
    <citation>MacNeill AJ, Gronchi A, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Barretta F, Raut CP, Strauss DC. Postoperative Morbidity After Radical Resection of Primary Retroperitoneal Sarcoma: A Report From the Transatlantic RPS Working Group. Ann Surg. 2018 May;267(5):959-964. doi: 10.1097/SLA.0000000000002250.</citation>
    <PMID>28394870</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>March 29, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sarcoma</keyword>
  <keyword>Surgery</keyword>
  <keyword>Multivisceral resection</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Radiation Therapy</keyword>
  <keyword>Patients' Registry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</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/NCT03838718
org study id: 201/16
nct id: NCT03838718
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgery is currently the only potentially curative treatment modality for localized
      retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly
      retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective
      analysis of high quality data is a top priority.

      Primary Objectives of this study are:

        -  to prospectively collect standardized clinical data and radiological and pathological
           material from primary RPS patients treated with surgery at reference centers.

        -  patient outcome will be evaluated in terms of overall survival (OS), disease-free
           survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant
           metastasis (DM).

      Secondary Objectives:

        -  to estimate the efficacy and safety of surgical treatment, including extended surgical
           approach to primary RPS;

        -  to prospectively evaluate the impact of multimodality therapy, including radiation
           therapy and chemotherapy;

        -  to identify clinical, radiological and pathological characteristics that may influence
           the oncological outcome or may be used as predictors of LR/DM/OS. These may be important
           biomarkers of disease;

        -  to utilize collected pathological material for research collaborations.
Retroperitoneal sarcomas (RPS) are rare tumors accounting for 10-15% of all soft tissue
      sarcomas (STS). They arise between retroperitoneal organs and among vital structures (ie
      major abdominal vessels) in an anatomical compartment that is not readily accessible by
      physical examination. Four main histotypes account for about 80% of all cases:
      well-differentiated liposarcoma (WDLPS), dedifferentiated liposarcoma (DDLPS), leiomyosarcoma
      (LMS) and solitary fibrous tumor (SFT).

      Compared to sarcomas at other anatomic sites, RPS are burdened by a higher local recurrence
      (LR) rate (50% at 5 years) and a poorer overall survival (OS) rate (50% at 5-years). The
      natural history of RPS as a whole group reflects the strong tendency of lipomatous tumors
      (WDLPS and DDLPS, which account for about 50% of RPS) to recur locally. Indeed, outcome of
      primary RPS is highly related to the histological subtype.

      WDLPS are characterized by a relatively lower LR rate, negligible metastatic potential and a
      favorable overall survival. These tumors however, still may recur locally even years after
      the primary resection. Intermediate grade DDLPS are characterized by a strong tendency to
      recur locally and low metastatic potential. High grade DDLPS has a high risk of both local
      recurrence and distant metastasis. LMS are usually intermediate or high-grade tumors with a
      strong tendency to develop distant metastasis; with an adequate resection, it is relatively
      common to obtain a durable local control. Classic SFT usually fare well after surgery, with a
      low rate of local recurrence and distant metastasis.

      Historically, surgery emerged as the only potentially curative option in the localized
      setting. In the last few years there has been lively debate as to how far should a surgeon
      resect in order to obtain a margin that could be considerate adequate. This issue is
      particularly challenging in this anatomical compartment where widening the surgical margins
      means resecting adjacent organs.

      Since 2002 an 'extended' surgical approach has been proposed for primary RPS patients. The
      concept was that surgical margins could be improved by encompassing the tumor with en-bloc
      resection of adjacent organs. The aim was to obtain reduced local recurrence and improved
      survival. This approach has proven to be effective. In particular, this surgical approach has
      been supported by an experimental model, retrospective comparisons, pathology studies
      demonstrating adjacent organ involvement, and reports of high rates of residual tumor at
      re-excision after conventional (non-extended) primary surgery. Finally, this approach has
      been shown to be safe after both short and long term follow-up.

      Radiotherapy is an option for RPS, especially in the preoperative setting, but currently the
      best evidence for efficacy comes form retrospective, mainly single-center, small size series.
      The results of such studies are controversial and high quality data are lacking. A randomized
      prospective study led by EORTC (STRASS) is ongoing but results are not expected for several
      years.

      The role of chemotherapy in the localized disease is also still under investigation,
      especially in high grade tumors. So far, there is no agreement on the optimal treatment
      strategy, even within reference centers, regarding the use of both chemo- and radiotherapy.
      In the recent years European and North-American centers joined the panel of expert and this
      led to the formation of the TransAtlantic Retroperitoneal Sarcoma Working Group (TARPSWG),
      which now consists of more than 50 representatives from sarcoma centers from all over the
      world.

      The aim of this collaboration is to expand the knowledge of the disease and formulate shared,
      standardized principles of treatment. A retrospective study has been carried out and recently
      published by the group to better define patients' outcome and prognostic factors after
      surgical resection of primary tumors. Other retrospective studies have been published
      focusing on post-relapse outcome, postsurgical morbidity and local recurrence treatment. This
      collaboration has also just recently led to the development of consensus guidelines for the
      treatment of primary and recurrent and metastatic RPS.

      To take advantage of the group collaboration, TARPSWG promoted a prospective collection of
      clinical, radiological and pathologic data for RPS.

      This study is aimed to prospectively collect standardized clinical data and radiological and
      pathological material from primary RPS patients treated with surgery at reference centers.
      Patient outcome will be evaluated in terms of overall survival (OS), disease-free survival
      (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).

      STUDY DESIGN

      This is a prospective, multicentric observational study under the supervision of TARPSWG
      (TransAtlantic Retroperitoneal Sarcoma Working Group) aimed to prospectively collect clinical
      data and prospectively store radiological and pathological material from patients affected by
      primary RPS treated with surgery.

      Patients with a diagnosis of primary RPS who meet the eligibility criteria will be invited to
      participate to the current study.

      Eligible patients will receive full information on the type of surgery proposed and on the
      data and material (radiological and pathological) that will be collected. Eligible and
      informed patients who give their consent to participate will be included in the Prospective
      Cohort Study (PCS) and will be followed-up prospectively.

      A data collection form including patient and tumor-related factors, treatment variables,
      follow-up findings, development of and time to local recurrence and status at follow-up has
      been constructed and shared among all the participating centers.

      Each participating reference center will individually be able to have access to both cross
      sectional imaging (CT or MRI images) and pathological material (a representative formalin
      block of the tumor). Whenever possible patient identifiers will be removed and patient
      confidentiality will be maintained. Any data shared between institutions will be deidentified
      and all measures to conceal patient identifiers will be taken.

      Each center will be responsible for data-entry and storage of its own patients' data,
      radiological examinations and pathological samples. At the time of the analysis each center
      is committed to provide the requested updated data to the group.

      Follow-up will be based on clinical evaluation and on cross sectional imaging (CT scan of the
      thorax and abdomen and/or contrast enhanced MRI of the abdomen) every 4 months for the first
      2 years, every 6 months until the 5th year and yearly thereafter.

      The overall duration of the project has not been fixed.

      Sample size

      The number of patients we plan to include in this prospective multicenter study will be 400
      patients per year.

      STATISTICAL CONSIDERATIONS Continuous variables will be summarized with appropriate summary
      statistics such as the mean, median, standard deviation, minimum and maximum. Categorical
      variables will be tabulated with frequencies and percentages. We will evaluate OS, DFS, CCI
      of DM and LR and correlate this with clinicopathologic factors such as histology, grade, type
      of surgery, etc.

      DATA COLLECTION Data entry will be performed by every participating center. Data will be
      collected in a standardized database, stored by every participating center, and shared with
      the group at the time of future studies. Data shared between institutions will be
      deidentified and whenever possible all measures to conceal patient identifiers and maintain
      patient confidentiality will be taken.

      ETHICS It is the responsibility of the investigator to have prospective approval of the trial
      protocol, informed consent forms, and other relevant documents, from the IRB/IEC. All
      correspondence with the IRB/IEC should be retained in the Investigator File.
observational model: Cohort
time perspective: Prospective
measure: Disease-free Survival
time frame: 10 years
description: Survival after surgery for primary RPS resection; any disease recurrence, local or distant, will be considered as an event at time of first radiological appearance.
measure: Overall Survival
time frame: 10 years
description: Overall Survival computed from date of surgery
measure: Crude cumulative incidence of Local recurrence
time frame: 10 years
description: CCI of Local recurrence computed from date of surgery, and defined as intrabdominal recurrent disease after complete resection
measure: Crude cumulative incidence of Distant metastasis
time frame: 10 years
description: CCI of distant metastasis computed from date of surgery, and defined as hepatic recurrence and / or extrabdominal recurrent disease
measure: Morbidity
time frame: 60 days
description: Postsurgical morbidity according to Clavien-Dindo classification
Biopsies, Surgical specimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Gronchi, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
last name: Marco Fiore, MD
role: Study Director
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
last name: Alessandro Gronchi, MD
phone: +39022390
phone ext: 3234
email: alessandro.gronchi@istitutotumori.mi.it
last name: Marco Fiore, MD
phone: +392390
phone ext: 2910
email: marco.fiore@istitutotumori.mi.it
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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contact: 
country: Australia
country: Canada
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Poland
country: Slovenia
country: Spain
country: United Kingdom
country: United States
url: http://www.tarpswg.org
description: website of Trans-Atlantic Retroperitoneal Sarcoma Working Group
citation: Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Raut CP. Variability in Patterns of Recurrence After Resection of Primary Retroperitoneal Sarcoma (RPS): A Report on 1007 Patients From the Multi-institutional Collaborative RPS Working Group. Ann Surg. 2016 May;263(5):1002-9. doi: 10.1097/SLA.0000000000001447.
PMID: 26727100
citation: Trans-Atlantic RPS Working Group. Management of primary retroperitoneal sarcoma (RPS) in the adult: a consensus approach from the Trans-Atlantic RPS Working Group. Ann Surg Oncol. 2015 Jan;22(1):256-63. doi: 10.1245/s10434-014-3965-2. Epub 2014 Oct 15.
PMID: 25316486
citation: MacNeill AJ, Gronchi A, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Barretta F, Raut CP, Strauss DC. Postoperative Morbidity After Radical Resection of Primary Retroperitoneal Sarcoma: A Report From the Transatlantic RPS Working Group. Ann Surg. 2018 May;267(5):959-964. doi: 10.1097/SLA.0000000000002250.
PMID: 28394870
responsible party type: Sponsor
mesh term: Sarcoma
sharing ipd: Undecided