<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/NCT04498767</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC 1945</org_study_id>
    <nct_id>NCT04498767</nct_id>
  </id_info>
  <brief_title>Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)</brief_title>
  <acronym>OligoRARE</acronym>
  <official_title>Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anticancer Fund, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rising Tide Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized open-label multicentre Phase III superiority study of the effect of&#xD;
      adding SBRT to the standard of care treatment on overall survival in patients with rare&#xD;
      oligometastatic cancers.&#xD;
&#xD;
      Patients will be randomized in a 1:1 ratio between current standard of care treatment vs.&#xD;
      standard of care treatment + SBRT to all sites of known metastatic disease.&#xD;
&#xD;
      The primary objective of this trial is to assess if the addition of stereotactic body&#xD;
      radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared&#xD;
      to standard of care treatment alone in patients with rare oligometastatic cancers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 10, 2021</start_date>
  <completion_date type="Anticipated">February 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">August 1, 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>Overall survival</measure>
    <time_frame>7.5 years from first patient in</time_frame>
    <description>Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>9 years from first patient in</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>9 years from first patient in</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to disease progression</measure>
    <time_frame>9 years from first patient in</time_frame>
    <description>Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to development of new metastatic lesions</measure>
    <time_frame>9 years from first patient in</time_frame>
    <description>Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:&#xD;
Development new metastatic lesions,&#xD;
Cancer-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to development of polymetastatic disease</measure>
    <time_frame>9 years from first patient in</time_frame>
    <description>Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events:&#xD;
Presence of more than 5 metastases at a specific timepoint during follow-up,&#xD;
Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible),&#xD;
Cancer-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0</measure>
    <time_frame>9 years from first patient in</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires</measure>
    <time_frame>9 years from first patient in</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires</measure>
    <time_frame>9 years from first patient in</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Gynecologic Cancer</condition>
  <condition>Skin Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Sarcoma</condition>
  <condition>Renal Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Upper Urinary Tract Carcinoma</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Hepatobiliary Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Small Bowel Cancer</condition>
  <condition>Esophageal Cancer</condition>
  <condition>Melanoma</condition>
  <condition>Colon Cancer</condition>
  <condition>Oligometastasis</condition>
  <arm_group>
    <arm_group_label>Arm 1: Standard of Care + palliative RT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).&#xD;
Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Standard of Care + SBRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental arm consists of SBRT (and standard of care systemic therapy). Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size &amp; location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.&#xD;
Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic body radiotherapy</intervention_name>
    <description>Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size &amp; location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.</description>
    <arm_group_label>Arm 2: Standard of Care + SBRT</arm_group_label>
    <other_name>SBRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Palliative RT</intervention_name>
    <description>Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).</description>
    <arm_group_label>Arm 1: Standard of Care + palliative RT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed malignancy with metastatic disease detected on imaging.&#xD;
             Biopsy of metastasis is preferred, but not required.&#xD;
&#xD;
          -  Controlled primary tumour, defined as:&#xD;
&#xD;
          -  at least 3 months since original tumour treated definitively, with no progression at&#xD;
             primary site&#xD;
&#xD;
          -  Total number of oligometastases of 1-5 including:&#xD;
&#xD;
          -  Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy&#xD;
             patient who had neurosurgical resection before trial inclusion are allowed and&#xD;
             resected brain metastases count to the total number of oligometastases&#xD;
&#xD;
          -  All sites of disease can be safely treated based on the judgement of an experienced&#xD;
             radiation oncologist&#xD;
&#xD;
          -  ECOG score 0-2&#xD;
&#xD;
          -  Life expectancy &gt; 6 months&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Before patient randomization, written informed consent must be given according to&#xD;
             ICH/GCP, and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary cancer of prostate, breast, lung or colorectal&#xD;
&#xD;
          -  Serious medical comorbidities precluding radiotherapy:&#xD;
&#xD;
          -  These include interstitial lung disease in patients requiring thoracic radiation,&#xD;
             Crohn's disease in patients where the GI tract will receive radiotherapy, or&#xD;
             ulcerative colitis where the bowel will receive radiotherapy and connective tissue&#xD;
             disorders such as lupus or scleroderma.&#xD;
&#xD;
          -  For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or&#xD;
             C)&#xD;
&#xD;
          -  Substantial overlap with a previously treated radiation volume. Prior radiotherapy in&#xD;
             general is allowed, as long as the composite plan meets dose constraints herein. For&#xD;
             patients treated previously with radiation, biological effective dose calculations&#xD;
             should be used to equate previous doses to the tolerance doses listed in the RTQA&#xD;
             Guidelines. All such cases should be discussed with one of the study coordinators&#xD;
&#xD;
          -  Brain metastases only, without extra-cerebral metastases&#xD;
&#xD;
          -  Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal&#xD;
             carcinomatosis&#xD;
&#xD;
          -  Maximum size of 6 cm for lesions outside the brain, except:&#xD;
&#xD;
          -  Bone metastases over 5 cm may be included, if in the opinion of the local radiation&#xD;
             oncologist it can be treated safely (e.g. rib, scapula, pelvis)&#xD;
&#xD;
          -  Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can&#xD;
             be eligible if surgical resection has been performed, but the surgical site counts&#xD;
             toward the total of up to 3 metastases.&#xD;
&#xD;
          -  Metastatic disease that invades any of the following: GI tract (including oesophagus,&#xD;
             stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin&#xD;
             metastases and lymphangiosis&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol and follow-up schedule; those conditions&#xD;
             should be discussed with the patient before randomization in the trial&#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>Matthias Guckenberger</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Piet Ost</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gasthuiszusters Antwerpen - Sint-Augustinus</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>EORTC HQ</last_name>
    <phone>+32 2 7744 1611</phone>
    <email>eortc@eortc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pieter Deseyne, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pieter Deseyne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gasthuiszusters Antwerpen - Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piet Ost, MD</last_name>
    </contact>
    <investigator>
      <last_name>Piet Ost, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Pasquier, MD</last_name>
    </contact>
    <investigator>
      <last_name>David Pasquier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonin Levy, MD</last_name>
    </contact>
    <investigator>
      <last_name>Antonin Levy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Alterio, MD</last_name>
    </contact>
    <investigator>
      <last_name>Daniela Alterio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hossein Hemmatazad, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hossein Hemmatazad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias Guckenberger, MD</last_name>
    </contact>
    <investigator>
      <last_name>Matthias Guckenberger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jennifer Sherriff, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jennifer Sherriff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - site: Chelsea, London</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Shane Zaidi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Italy</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oligometastatic cancer</keyword>
  <keyword>Stereotactic body radiotherapy</keyword>
  <keyword>SBRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04498767
org study id: EORTC 1945
nct id: NCT04498767
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized open-label multicentre Phase III superiority study of the effect of
      adding SBRT to the standard of care treatment on overall survival in patients with rare
      oligometastatic cancers.

      Patients will be randomized in a 1:1 ratio between current standard of care treatment vs.
      standard of care treatment + SBRT to all sites of known metastatic disease.

      The primary objective of this trial is to assess if the addition of stereotactic body
      radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared
      to standard of care treatment alone in patients with rare oligometastatic cancers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 7.5 years from first patient in
description: Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.
measure: Progression-free survival
time frame: 9 years from first patient in
measure: Disease-specific survival
time frame: 9 years from first patient in
measure: Time to disease progression
time frame: 9 years from first patient in
description: Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.
measure: Time to development of new metastatic lesions
time frame: 9 years from first patient in
description: Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:
Development new metastatic lesions,
Cancer-related death.
measure: Time to development of polymetastatic disease
time frame: 9 years from first patient in
description: Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events:
Presence of more than 5 metastases at a specific timepoint during follow-up,
Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible),
Cancer-related death.
measure: Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
time frame: 9 years from first patient in
measure: Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires
time frame: 9 years from first patient in
measure: Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires
time frame: 9 years from first patient in
arm group label: Arm 1: Standard of Care + palliative RT
arm group type: Active Comparator
description: Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).
Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy.
arm group label: Arm 2: Standard of Care + SBRT
arm group type: Experimental
description: The experimental arm consists of SBRT (and standard of care systemic therapy). Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size & location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation.
intervention type: Radiation
intervention name: Stereotactic body radiotherapy
description: Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size & location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
arm group label: Arm 2: Standard of Care + SBRT
other name: SBRT
intervention type: Radiation
intervention name: Palliative RT
description: Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).
arm group label: Arm 1: Standard of Care + palliative RT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthias Guckenberger
role: Principal Investigator
affiliation: University of Zurich
last name: Piet Ost
role: Principal Investigator
affiliation: Gasthuiszusters Antwerpen - Sint-Augustinus
last name: EORTC HQ
phone: +32 2 7744 1611
email: eortc@eortc.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
country: Belgium
country: France
country: Italy
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Kidney Neoplasms