<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/NCT02213497</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 01214</org_study_id>
    <nct_id>NCT02213497</nct_id>
  </id_info>
  <brief_title>Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer</brief_title>
  <official_title>Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with esophageal cancer to be treated with concurrent preoperative proton therapy&#xD;
      along with carboplatin and paclitaxel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton&#xD;
           radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for&#xD;
           esophageal cancer.&#xD;
&#xD;
        2. To estimate pathologic response rates by esophagectomy surgical specimens after&#xD;
           escalated doses of chemoradiotherapy.&#xD;
&#xD;
        3. To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to&#xD;
           predict treatment response to chemoradiotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>18F-FDG (Fluorodeoxyglucose) PET</intervention_name>
    <arm_group_label>Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <arm_group_label>Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <arm_group_label>Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal&#xD;
             to the carina&#xD;
&#xD;
          -  Patients with AJCC 7th edition clinical stage IIB-IIIC&#xD;
&#xD;
          -  Patient must be &gt;18 years of age.&#xD;
&#xD;
          -  Patients must have an ECOG Performance Status of 0-1&#xD;
&#xD;
          -  Patients must be able to provide informed consent.&#xD;
&#xD;
          -  Patients must be surgical candidates with adequate hematologic, renal, hepatic and&#xD;
             pulmonary function&#xD;
&#xD;
          -  serum AST and ALT &lt; 2 times the upper limit of normal&#xD;
&#xD;
          -  Patients must have bilirubin &lt; 1.5 × normal.&#xD;
&#xD;
          -  WBC &gt; 3000/mm3, platelets &gt; 100,000 mm3.&#xD;
&#xD;
          -  Hemoglobin &gt; 10 g/dL serum creatinine &lt; 1.5 times the upper limit of normal&#xD;
&#xD;
          -  Women of child-bearing potential as long as she agrees to use a recognized method of&#xD;
             birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.).&#xD;
             Hysterectomy or menopause must be clinically documented.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should&#xD;
             be measured by endoscopic findings, width should be measured by diagnostic CT or CT&#xD;
             portion of PET/CT)&#xD;
&#xD;
          -  Patients with primary tumors located at or above the carina&#xD;
&#xD;
          -  Prior or simultaneous malignancies within the past two years (other than cutaneous&#xD;
             squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)&#xD;
&#xD;
          -  Pregnant women, women planning to become pregnant and women that are nursing&#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>John Plastaras, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Esophageal Cancer</keyword>
  <keyword>Neoadjuvant</keyword>
  <keyword>Proton Beam Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_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/NCT02213497
org study id: UPCC 01214
nct id: NCT02213497
lead sponsor: 
has dmc: Yes
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy
      along with carboplatin and paclitaxel.
1. To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton
           radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for
           esophageal cancer.

        2. To estimate pathologic response rates by esophagectomy surgical specimens after
           escalated doses of chemoradiotherapy.

        3. To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to
           predict treatment response to chemoradiotherapy
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Adverse Events
time frame: 3 years
arm group label: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
arm group type: Experimental
description: Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
intervention type: Radiation
intervention name: 18F-FDG (Fluorodeoxyglucose) PET
arm group label: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
intervention type: Drug
intervention name: Carboplatin
arm group label: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
intervention type: Drug
intervention name: Paclitaxel
arm group label: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Plastaras, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Fluorodeoxyglucose F18