<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/NCT03254420</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-URC2015/33</org_study_id>
    <nct_id>NCT03254420</nct_id>
  </id_info>
  <brief_title>Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.</brief_title>
  <acronym>RCMIGI</acronym>
  <official_title>Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</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>
      The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology&#xD;
      using electromagnetic transponders implanted within the prostate. It is a real-time target&#xD;
      tracking system that takes into account both inter- and intrafractional target motion. So the&#xD;
      exact position and movement of the prostate can be determined during radiation therapy&#xD;
      treatment.&#xD;
&#xD;
      The aim of this study is to assess pelvic late toxicity rate after intensity-modulated&#xD;
      radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In&#xD;
      this randomized study, patients will receive IGRT treatment using the Calypso system or a&#xD;
      conventional IGRT treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference&#xD;
      treatments for localized prostate cancer. Prostate was initially thought to be a non-moving&#xD;
      target, but the newest reports have raised the contrary as evidence. Image-guided&#xD;
      radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which&#xD;
      enables to take into account interfractional prostate motion before treatment.&#xD;
&#xD;
      The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology&#xD;
      using electromagnetic transponders implanted within the prostate. It is a real-time target&#xD;
      tracking system that takes into account both inter- and intrafractional target motion. So the&#xD;
      exact position and movement of the prostate can be determined during radiation therapy&#xD;
      treatment.&#xD;
&#xD;
      As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ&#xD;
      motion, margin reduction can reasonably be considered in case of target motion management&#xD;
      improvement.&#xD;
&#xD;
      To date, no prospective randomized clinical data is available using this technique for the&#xD;
      treatment of low- or intermediate-risk prostate cancer patients with modern standard&#xD;
      fractionation radiotherapy and image guidance.&#xD;
&#xD;
      The aim of this study is to assess pelvic late toxicity rate after intensity-modulated&#xD;
      radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In&#xD;
      this randomized study, patients will receive IGRT treatment using the Calypso system or a&#xD;
      conventional IGRT treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 30, 2016</start_date>
  <completion_date type="Anticipated">December 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2028</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>assessment of grade &gt; 2 late pelvic toxicities</measure>
    <time_frame>up to 2 years post treatment</time_frame>
    <description>assessment of grade &gt; 2 late pelvic toxicities between 3 months and 2 years after radiation period</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Image-guided radiation therapy (IGRT) with standard margins</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>moderate hypofractionation during 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calypso tracking system with margin reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Calypso beacon implant</intervention_name>
    <description>Calypso beacon implant before radiotherapy</description>
    <arm_group_label>Calypso tracking system with margin reduction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>moderate hypofractionation Radiotherapy</intervention_name>
    <description>moderate hypofractionation Radiotherapy</description>
    <arm_group_label>Calypso tracking system with margin reduction</arm_group_label>
    <arm_group_label>Image-guided radiation therapy (IGRT) with standard margins</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Localized prostate cancer, histologically proven.&#xD;
&#xD;
          -  No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral&#xD;
             lymph node dissection is not mandatory if lymph node involvement risk is low according&#xD;
             to the Partin tables).&#xD;
&#xD;
          -  Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2&#xD;
             and Gleason &lt; 8 and PSA &lt; 20 ng/ml) (appendix 3).&#xD;
&#xD;
          -  No grade &gt; 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03&#xD;
             scale.&#xD;
&#xD;
          -  Performance status ECOG ≤ 1.&#xD;
&#xD;
          -  No hip prosthesis or metallic vascular graft near the prostate.&#xD;
&#xD;
          -  No endopenian stent.&#xD;
&#xD;
          -  No pace maker, implanted defibrillator or neurostimulator.&#xD;
&#xD;
          -  No allergy to local anesthetics.&#xD;
&#xD;
          -  No irreversible anticoagulation or antiplatelet treatment for the implantation period.&#xD;
&#xD;
          -  Pelvic and abdominal anatomy compatible with the use of the Calypso® system&#xD;
             (predictive detector to fiducials distance less than 19 cm, evaluated on planning&#xD;
             CT-scan) (distance from skin surface to prostate center less than 17 cm).&#xD;
&#xD;
          -  Patient aged ≥ 18 and less than 80 years old.&#xD;
&#xD;
          -  Dated and signed written informed consent available.&#xD;
&#xD;
          -  Patients must be affiliated to a French Social Security System.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication of pelvic nodes irradiation.&#xD;
&#xD;
          -  Prior pelvic irradiation.&#xD;
&#xD;
          -  Biopsy-proven seminal vesicle invasion.&#xD;
&#xD;
          -  Prior bilateral orchiectomy.&#xD;
&#xD;
          -  Prior radical prostatectomy.&#xD;
&#xD;
          -  Other malignancy except adequately-treated basal cell carcinoma of the skin or other&#xD;
             malignancy from which the patient has been disease-free for at least 5 years.&#xD;
&#xD;
          -  Psychological, familial, sociological or geographical condition potentially hampering&#xD;
             compliance with the study protocol and follow-up schedule; those conditions should be&#xD;
             discussed with the patient before registration in the trial.&#xD;
&#xD;
          -  Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary embolism,&#xD;
             etc.).&#xD;
&#xD;
          -  Known VIH positive patients (no specific test needed).&#xD;
&#xD;
          -  Known homozygote ATM Mutation (Ataxia telengiectasia).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Riou Olivier</last_name>
    <role>Study Chair</role>
    <affiliation>Institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut regional du Cancer - Val d Aurelle</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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    <citation>Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33. doi: 10.1158/1078-0432.CCR-04-2634.</citation>
    <PMID>16243816</PMID>
  </reference>
  <reference>
    <citation>Azria D, Betz M, Bourgier C, Jeanneret Sozzi W, Ozsahin M. Identifying patients at risk for late radiation-induced toxicity. Crit Rev Oncol Hematol. 2012 Dec;84 Suppl 1:e35-41. doi: 10.1016/j.critrevonc.2010.08.003. Epub 2010 Sep 24.</citation>
    <PMID>20869261</PMID>
  </reference>
  <reference>
    <citation>Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.</citation>
    <PMID>8433390</PMID>
  </reference>
  <reference>
    <citation>Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.</citation>
    <PMID>9187685</PMID>
  </reference>
  <reference>
    <citation>Nyaga VN, Arbyn M, Aerts M. Metaprop: a Stata command to perform meta-analysis of binomial data. Arch Public Health. 2014 Nov 10;72(1):39. doi: 10.1186/2049-3258-72-39. eCollection 2014.</citation>
    <PMID>25810908</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_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/NCT03254420
org study id: ICM-URC2015/33
nct id: NCT03254420
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology
      using electromagnetic transponders implanted within the prostate. It is a real-time target
      tracking system that takes into account both inter- and intrafractional target motion. So the
      exact position and movement of the prostate can be determined during radiation therapy
      treatment.

      The aim of this study is to assess pelvic late toxicity rate after intensity-modulated
      radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In
      this randomized study, patients will receive IGRT treatment using the Calypso system or a
      conventional IGRT treatment.
Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference
      treatments for localized prostate cancer. Prostate was initially thought to be a non-moving
      target, but the newest reports have raised the contrary as evidence. Image-guided
      radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which
      enables to take into account interfractional prostate motion before treatment.

      The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology
      using electromagnetic transponders implanted within the prostate. It is a real-time target
      tracking system that takes into account both inter- and intrafractional target motion. So the
      exact position and movement of the prostate can be determined during radiation therapy
      treatment.

      As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ
      motion, margin reduction can reasonably be considered in case of target motion management
      improvement.

      To date, no prospective randomized clinical data is available using this technique for the
      treatment of low- or intermediate-risk prostate cancer patients with modern standard
      fractionation radiotherapy and image guidance.

      The aim of this study is to assess pelvic late toxicity rate after intensity-modulated
      radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In
      this randomized study, patients will receive IGRT treatment using the Calypso system or a
      conventional IGRT treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: assessment of grade > 2 late pelvic toxicities
time frame: up to 2 years post treatment
description: assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period
arm group label: Image-guided radiation therapy (IGRT) with standard margins
arm group type: Active Comparator
description: moderate hypofractionation during 4 weeks
arm group label: Calypso tracking system with margin reduction
arm group type: Experimental
description: moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before
intervention type: Device
intervention name: Calypso beacon implant
description: Calypso beacon implant before radiotherapy
arm group label: Calypso tracking system with margin reduction
intervention type: Radiation
intervention name: moderate hypofractionation Radiotherapy
description: moderate hypofractionation Radiotherapy
arm group label: Calypso tracking system with margin reduction
arm group label: Image-guided radiation therapy (IGRT) with standard margins
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Riou Olivier
role: Study Chair
affiliation: Institut régional du Cancer de Montpellier
facility: 
country: France
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PMID: 16243816
citation: Azria D, Betz M, Bourgier C, Jeanneret Sozzi W, Ozsahin M. Identifying patients at risk for late radiation-induced toxicity. Crit Rev Oncol Hematol. 2012 Dec;84 Suppl 1:e35-41. doi: 10.1016/j.critrevonc.2010.08.003. Epub 2010 Sep 24.
PMID: 20869261
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PMID: 8433390
citation: Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
PMID: 9187685
citation: Nyaga VN, Arbyn M, Aerts M. Metaprop: a Stata command to perform meta-analysis of binomial data. Arch Public Health. 2014 Nov 10;72(1):39. doi: 10.1186/2049-3258-72-39. eCollection 2014.
PMID: 25810908
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No