<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/NCT02228954</url>
  </required_header>
  <id_info>
    <org_study_id>IMPACT-RCC study</org_study_id>
    <nct_id>NCT02228954</nct_id>
  </id_info>
  <brief_title>IMaging PAtients for Cancer Drug selecTion - Renal Cell Carcinoma (IMPACT-RCC)</brief_title>
  <acronym>IMPACT-RCC</acronym>
  <official_title>Watchful Waiting in Patients With Good and Intermediate Risk Metastatic Renal Cell Carcinoma; an Imaging Guided Observational Approach. Part of: Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging. IMPACT Study: Imaging Patients for Cancer Drug Selection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <brief_summary>
    <textblock>
      Rationale. In part of the patients with good and intermediate risk metastatic renal cell&#xD;
      carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is&#xD;
      not necessary. By now, the investigators are not able to identify those patients with&#xD;
      indolent disease and the minor group of patients with rapidly progressive disease. In&#xD;
      patients with indolent disease, a watchful waiting period is preferred, since their quality&#xD;
      of life will not be unnecessary hampered by adverse events and therapy resistance is not&#xD;
      induced. This study aims to identify those patients for whom a watchful waiting period is&#xD;
      possible by molecular imaging. Furthermore several types of systemic therapy are possible&#xD;
      once the progression is proven. These systemic treatments are comparable in terms of&#xD;
      efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary&#xD;
      objective, the usefulness of a decision aid guiding the choice of the patients is studied.&#xD;
&#xD;
      Objectives.&#xD;
&#xD;
      To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful&#xD;
      waiting, the added value beyond clinical work-up of:&#xD;
&#xD;
        1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid&#xD;
           progression (≤ 2 months after the baseline scan) under watchful waiting.&#xD;
&#xD;
        2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged&#xD;
           indolent (≥12 months after the baseline scan) disease under watchful waiting.&#xD;
&#xD;
      To assess the value of a therapy choice decision aid for patients with progressive disease.&#xD;
&#xD;
      Study design. This is a multicenter non-blinded prospective observational study in 80 good&#xD;
      and intermediate prognosis mRCC patients.&#xD;
&#xD;
      Study population. Patients with good or intermediate prognosis mRCC according to the Heng&#xD;
      criteria, ≥18 years, without contra-indications for a watchful waiting period, able to&#xD;
      provide informed consent.&#xD;
&#xD;
      Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the&#xD;
      watchful waiting period, disease evaluation by CT according to the RECIST criteria will be&#xD;
      made frequently, until established progressive disease. At that moment, a second FDG-PET-CT&#xD;
      and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second&#xD;
      89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to&#xD;
      choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α&#xD;
      with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy&#xD;
      (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a&#xD;
      separate phase II study.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness.&#xD;
&#xD;
      At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the&#xD;
      watchful waiting period CT's will be made. During therapy, follow-up will include standard&#xD;
      laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of&#xD;
      the medication and adverse events as a consequence of the tumor biopsies may occur. The&#xD;
      radiation exposure of both PET investigations is acceptable and requires no shielding after&#xD;
      injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or&#xD;
      stabilization. All three treatment choices has proven clinical benefit in this patient&#xD;
      population. The risks of participation into the RIT trial are described in the phase II trial&#xD;
      protocol, which already has been judged by the Medical Ethics Review Committee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">October 19, 2021</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Time to progression</measure>
    <time_frame>1-5 years (End of study)</time_frame>
    <description>To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of:&#xD;
FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting.&#xD;
FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and physician questionnaires on the added value of the decision aid</measure>
    <time_frame>1-5 years (End of study)</time_frame>
    <description>To assess the value of a therapy choice decision aid for patients with progressive disease</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Clear-cell Metastatic Renal Cell Carcinoma</condition>
  <condition>Kidney Neoplasms</condition>
  <arm_group>
    <arm_group_label>Renal Cell Cancer</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Molecular imaging</intervention_name>
    <arm_group_label>Renal Cell Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with good or intermediate prognosis mccRCC according to the Heng criteria, ≥18&#xD;
        years, without contra-indications for a watchful waiting period, able to provide informed&#xD;
        consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological documented mRCC with a clear cell component&#xD;
&#xD;
          -  Good or intermediate prognosis, defined as none (good risk) or 1-2 intermediate risk)&#xD;
             of the below mentioned risk factors:&#xD;
&#xD;
               -  Karnofsky performance &lt;80&#xD;
&#xD;
               -  Time from diagnosis detection of metastases &lt; 1 year&#xD;
&#xD;
               -  Haemoglobin &lt; lower limit of normal (LLN)&#xD;
&#xD;
               -  Corrected calcium &gt; upper limit of normal (ULN)&#xD;
&#xD;
               -  Neutrophils &gt; ULN&#xD;
&#xD;
               -  Platelets &gt; ULN&#xD;
&#xD;
          -  A watchful waiting period for 2 months is considered an option according to treating&#xD;
             medical oncologist&#xD;
&#xD;
          -  No prior systemic treatment for RCC (also non-adjuvant)&#xD;
&#xD;
          -  Time from diagnosis of metastases &lt; 3 months&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated central nervous system metastases, or symptomatic intracerebral metastases.&#xD;
&#xD;
          -  Pregnant or breast feeding women.&#xD;
&#xD;
          -  Any serious and/or unstable pre-existing medical, psychiatric, or other condition that&#xD;
             would make the subject inappropriate for study participation including any serious&#xD;
             condition that could interfere with subject's safety, provision of informed consent,&#xD;
             or compliance with study procedure.&#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>VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clear-cell metastatic renal cell carcinoma</keyword>
  <keyword>Positron-Emission Tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Kidney Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02228954
org study id: IMPACT-RCC study
nct id: NCT02228954
lead sponsor: 
collaborator: 
Rationale. In part of the patients with good and intermediate risk metastatic renal cell
      carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is
      not necessary. By now, the investigators are not able to identify those patients with
      indolent disease and the minor group of patients with rapidly progressive disease. In
      patients with indolent disease, a watchful waiting period is preferred, since their quality
      of life will not be unnecessary hampered by adverse events and therapy resistance is not
      induced. This study aims to identify those patients for whom a watchful waiting period is
      possible by molecular imaging. Furthermore several types of systemic therapy are possible
      once the progression is proven. These systemic treatments are comparable in terms of
      efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary
      objective, the usefulness of a decision aid guiding the choice of the patients is studied.

      Objectives.

      To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful
      waiting, the added value beyond clinical work-up of:

        1. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid
           progression (≤ 2 months after the baseline scan) under watchful waiting.

        2. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged
           indolent (≥12 months after the baseline scan) disease under watchful waiting.

      To assess the value of a therapy choice decision aid for patients with progressive disease.

      Study design. This is a multicenter non-blinded prospective observational study in 80 good
      and intermediate prognosis mRCC patients.

      Study population. Patients with good or intermediate prognosis mRCC according to the Heng
      criteria, ≥18 years, without contra-indications for a watchful waiting period, able to
      provide informed consent.

      Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the
      watchful waiting period, disease evaluation by CT according to the RECIST criteria will be
      made frequently, until established progressive disease. At that moment, a second FDG-PET-CT
      and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second
      89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to
      choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α
      with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy
      (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a
      separate phase II study.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness.

      At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the
      watchful waiting period CT's will be made. During therapy, follow-up will include standard
      laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of
      the medication and adverse events as a consequence of the tumor biopsies may occur. The
      radiation exposure of both PET investigations is acceptable and requires no shielding after
      injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or
      stabilization. All three treatment choices has proven clinical benefit in this patient
      population. The risks of participation into the RIT trial are described in the phase II trial
      protocol, which already has been judged by the Medical Ethics Review Committee.
observational model: Cohort
time perspective: Prospective
measure: Time to progression
time frame: 1-5 years (End of study)
description: To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of:
FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting.
FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting.
measure: Patient and physician questionnaires on the added value of the decision aid
time frame: 1-5 years (End of study)
description: To assess the value of a therapy choice decision aid for patients with progressive disease
arm group label: Renal Cell Cancer
intervention type: Procedure
intervention name: Molecular imaging
arm group label: Renal Cell Cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Kidney Neoplasms