<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/NCT03234842</url>
  </required_header>
  <id_info>
    <org_study_id>UFPTI 1605-ES01</org_study_id>
    <nct_id>NCT03234842</nct_id>
  </id_info>
  <brief_title>Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer</brief_title>
  <acronym>ES01</acronym>
  <official_title>A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate if proton beam therapy as part of chemoradiation results in a&#xD;
      decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation&#xD;
      therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac&#xD;
      function, quality of life, and compare acute and late toxicities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial&#xD;
      eligibility. If patients decline proton radiotherapy or are otherwise unable to receive&#xD;
      proton therapy they will be included in x-ray cohort (group 2).&#xD;
&#xD;
      Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly&#xD;
      carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly&#xD;
      chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should&#xD;
      begin within 48 hours of beginning radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    non-accrual&#xD;
  </why_stopped>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">December 11, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation</measure>
    <time_frame>Approximately 12 months after radiation therapy</time_frame>
    <description>Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare quality of life</measure>
    <time_frame>Approximately 12 months after radiation therapy</time_frame>
    <description>Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare outcomes for local control</measure>
    <time_frame>Approximately 12 months after radiation therapy</time_frame>
    <description>Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare outcomes for progression free survival</measure>
    <time_frame>Approximately 12 months after radiation therapy</time_frame>
    <description>Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare overall survival rates</measure>
    <time_frame>Approximately 12 months after radiation therapy</time_frame>
    <description>Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Proton</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Photon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Proton Beam Therapy</intervention_name>
    <description>59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses</description>
    <arm_group_label>Proton</arm_group_label>
    <other_name>Proton Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Photon Radiation Therapy</intervention_name>
    <description>59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses</description>
    <arm_group_label>Photon</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Concurrent weekly chemotherapy at standard doses</description>
    <arm_group_label>Photon</arm_group_label>
    <arm_group_label>Proton</arm_group_label>
    <other_name>Carboplatin</other_name>
    <other_name>Paclitaxel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be at least 18 years at the time of consent.&#xD;
&#xD;
          -  Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the&#xD;
             thoracic esophagus or esophagogastric junction.&#xD;
&#xD;
          -  Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be&#xD;
             cT1b-T4, N0-N3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cervical esophageal carcinoma.&#xD;
&#xD;
          -  Prior radiotherapy with fields overlapping the current esophageal cancer.&#xD;
&#xD;
          -  Patients with cT1a disease.&#xD;
&#xD;
          -  Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to&#xD;
             exclude fistula.&#xD;
&#xD;
          -  Patients with distant metastatic disease.&#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>Michael Rutenberg, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UF Health Proton Therapy Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Proton Therapy Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Esophagus</keyword>
  <keyword>Proton</keyword>
  <keyword>Radiation</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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03234842
org study id: UFPTI 1605-ES01
nct id: NCT03234842
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will evaluate if proton beam therapy as part of chemoradiation results in a
      decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation
      therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac
      function, quality of life, and compare acute and late toxicities.
Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial
      eligibility. If patients decline proton radiotherapy or are otherwise unable to receive
      proton therapy they will be included in x-ray cohort (group 2).

      Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly
      carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly
      chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should
      begin within 48 hours of beginning radiotherapy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation
time frame: Approximately 12 months after radiation therapy
description: Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
measure: Compare quality of life
time frame: Approximately 12 months after radiation therapy
description: Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy
measure: Compare outcomes for local control
time frame: Approximately 12 months after radiation therapy
description: Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
measure: Compare outcomes for progression free survival
time frame: Approximately 12 months after radiation therapy
description: Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
measure: Compare overall survival rates
time frame: Approximately 12 months after radiation therapy
description: Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
arm group label: Proton
arm group type: Experimental
description: Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
arm group label: Photon
arm group type: Active Comparator
description: Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
intervention type: Radiation
intervention name: Proton Beam Therapy
description: 59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
arm group label: Proton
other name: Proton Therapy
intervention type: Radiation
intervention name: Photon Radiation Therapy
description: 59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
arm group label: Photon
other name: IMRT
intervention type: Drug
intervention name: Chemotherapy
description: Concurrent weekly chemotherapy at standard doses
arm group label: Photon
arm group label: Proton
other name: Carboplatin
other name: Paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Rutenberg, MD, PhD
role: Principal Investigator
affiliation: UF Health Proton Therapy Institute
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Esophageal Neoplasms
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: Undecided