<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/NCT03810651</url>
  </required_header>
  <id_info>
    <org_study_id>17-014386</org_study_id>
    <nct_id>NCT03810651</nct_id>
  </id_info>
  <brief_title>Pencil Beam Scanning in Patients With Renal Tumors</brief_title>
  <official_title>Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</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>
      This is a pilot study to assess acute toxicity in patients receiving flank irradiation using&#xD;
      proton therapy for renal tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are&#xD;
      treated with multimodality therapy which may include surgery, chemotherapy, and radiation.&#xD;
      While long-term disease control is excellent, these patients remain at risk for early and&#xD;
      late toxicities partially from radiation. There have been no significant changes to&#xD;
      traditional photon radiation fields, which encompass the post-operative bed, anterior&#xD;
      abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is&#xD;
      characterized by Bragg peak dose deposition and high conformality of dose to target regions,&#xD;
      is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam&#xD;
      scanning proton therapy (PBS-PT) to:&#xD;
&#xD;
        -  result in low acute gastrointestinal toxicity in patients receiving radiation therapy&#xD;
           for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient&#xD;
           reported health related quality of life outcomes&#xD;
&#xD;
        -  decrease the duration of radiation therapy&#xD;
&#xD;
        -  compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon&#xD;
           fields&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 26, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades].</measure>
    <time_frame>90 days</time_frame>
    <description>Acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors. Acute toxicity is defined as any non-hematologic toxicity that occurs within 90 days following the start of proton therapy. NCI Common toxicity criteria (CTC Version 4.0) grades will be employed. Individual category content listings are available to investigators at http://ctep.cancer.gov, with attention to the following System Organ Classes and CTCAE Adverse Events: General Disorders and Administration Site Conditions, Hepatobiliary Disorders, Blood and Lymphatic System Disorders, Gastrointestinal Disorders, Renal and Urinary Disorders, Injury, poisoning, or procedural complications, Metabolism and nutrition disorders, and Benign, Malignant, and Unspecified Neoplasms.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Renal Tumor</condition>
  <condition>Wilms Tumor</condition>
  <arm_group>
    <arm_group_label>Renal tumors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care. Patients may receive an investigation drug for Wilms or CCSK given concurrently or within the first four weeks of the first fraction of proton therapy administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proton beam radiation using pencil beam scanning</intervention_name>
    <description>Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions</description>
    <arm_group_label>Renal tumors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than 30 years of age&#xD;
&#xD;
          -  Diagnosis&#xD;
&#xD;
             a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require&#xD;
             radiation therapy as standard of care including&#xD;
&#xD;
               1. Any patient with favorable histology (FH), stage III disease&#xD;
&#xD;
               2. Any patient with focal or diffuse anaplasia&#xD;
&#xD;
               3. Any patient with CCSK&#xD;
&#xD;
          -  The patient is a candidate for external beam radiotherapy based on standard of care&#xD;
             for treatment of Wilms tumor or CCSK&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior radiotherapy to the region of the study cancer&#xD;
&#xD;
          -  Chemotherapy administered for diagnosis of Wilms tumor or CCSK&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Hill-Kayser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine Hill-Kayser, MD</last_name>
    <phone>215-590-2810</phone>
    <email>hill@uphs.upenn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ratnakar Patti</last_name>
    <email>PATTIR@chop.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Hill-Kayser, MD</last_name>
      <phone>215-590-2810</phone>
      <email>hill@uphs.upenn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ratnakar Patti</last_name>
      <email>PATTIR@chop.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>Neoplasms</mesh_term>
    <mesh_term>Wilms Tumor</mesh_term>
    <mesh_term>Kidney 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/NCT03810651
org study id: 17-014386
nct id: NCT03810651
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot study to assess acute toxicity in patients receiving flank irradiation using
      proton therapy for renal tumors.
Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are
      treated with multimodality therapy which may include surgery, chemotherapy, and radiation.
      While long-term disease control is excellent, these patients remain at risk for early and
      late toxicities partially from radiation. There have been no significant changes to
      traditional photon radiation fields, which encompass the post-operative bed, anterior
      abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is
      characterized by Bragg peak dose deposition and high conformality of dose to target regions,
      is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam
      scanning proton therapy (PBS-PT) to:

        -  result in low acute gastrointestinal toxicity in patients receiving radiation therapy
           for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient
           reported health related quality of life outcomes

        -  decrease the duration of radiation therapy

        -  compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon
           fields
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades].
time frame: 90 days
description: Acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors. Acute toxicity is defined as any non-hematologic toxicity that occurs within 90 days following the start of proton therapy. NCI Common toxicity criteria (CTC Version 4.0) grades will be employed. Individual category content listings are available to investigators at http://ctep.cancer.gov, with attention to the following System Organ Classes and CTCAE Adverse Events: General Disorders and Administration Site Conditions, Hepatobiliary Disorders, Blood and Lymphatic System Disorders, Gastrointestinal Disorders, Renal and Urinary Disorders, Injury, poisoning, or procedural complications, Metabolism and nutrition disorders, and Benign, Malignant, and Unspecified Neoplasms.
arm group label: Renal tumors
arm group type: Other
description: Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care. Patients may receive an investigation drug for Wilms or CCSK given concurrently or within the first four weeks of the first fraction of proton therapy administration.
intervention type: Other
intervention name: Proton beam radiation using pencil beam scanning
description: Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
arm group label: Renal tumors
criteria: 
gender: All
minimum age: 0 Years
maximum age: 30 Years
healthy volunteers: No
last name: Christine Hill-Kayser, MD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
last name: Christine Hill-Kayser, MD
phone: 215-590-2810
email: hill@uphs.upenn.edu
last name: Ratnakar Patti
email: PATTIR@chop.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Wilms Tumor
mesh term: Kidney Neoplasms
sharing ipd: No