<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/NCT03285035</url>
  </required_header>
  <id_info>
    <org_study_id>WG2015029</org_study_id>
    <nct_id>NCT03285035</nct_id>
  </id_info>
  <brief_title>Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer</brief_title>
  <acronym>Cryotherapy</acronym>
  <official_title>Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Regional Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cryoablation combined with chemotherapy on the quality of life of patients with non&#xD;
      resectable esophageal or gastroesophageal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm prospective study to determine the effect of cryoablation combined with&#xD;
      chemotherapy on the quality of life of patients with non resectable esophageal or&#xD;
      gastroesophageal cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Anticipated">January 13, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 13, 2020</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>Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline</measure>
    <time_frame>1 to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as assessed by CTCAE 4.03.</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined</measure>
    <time_frame>1 to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoassays will be obtained before and after treatment</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local tumor control will be compared to systemic tumor control</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival while on cryotherapy and systemic chemotherapy will be measured.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>Non-operable esophageal cancer</arm_group_label>
    <description>Cryotherapy treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.</intervention_name>
    <description>Upper endoscopy with cryotherapy using liquid nitrogen.</description>
    <arm_group_label>Non-operable esophageal cancer</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Archival tissue or fresh tissue from gastrointestinal biopsies used for diagnostic purposes.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with non resectable esophageal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has esophageal or gastroesophageal cancer and will be receiving chemotherapy&#xD;
&#xD;
          -  Dysphagia score of 1, 2, 3 or 4.&#xD;
&#xD;
          -  Age ≥18 years old&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4&#xD;
&#xD;
          -  Deemed not a candidate for esophageal cancer surgical resection&#xD;
&#xD;
          -  Female subjects must be either post-menopausal, surgically sterilized, or willing to&#xD;
             use an acceptable method of birth control (i.e., total abstinence, birth control&#xD;
             pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants,&#xD;
             or condoms plus a spermicide) for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status greater than 2&#xD;
&#xD;
          -  Patient who received radiation treatment in the prior 8 weeks&#xD;
&#xD;
          -  Known brain metastases causing cranial nerve deficits which can cause dysphagia&#xD;
&#xD;
          -  Inability to undergo an esophagogastroduodenoscopy (EGD)&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Surgery or anatomy where capacity of stomach is reduced making cryotherapy&#xD;
             contraindicated&#xD;
&#xD;
          -  Patients with tracheoesophageal fistula&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Toufic Kachaamy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Regional Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Coordinator</last_name>
    <phone>623-207-3000</phone>
    <email>WesternTrials@ctca-hope.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Research Nurse, RN</last_name>
    <phone>623-207-3000</phone>
    <email>WesternTrials@ctca-hope.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Western Regional Medical Center, Inc.</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85338</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toufic Kachaamy, MD</last_name>
      <phone>623-207-3000</phone>
      <email>WesternTrials@ctca-hope.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cryotherapy</keyword>
  <keyword>Palliation</keyword>
  <keyword>Dysphagia</keyword>
  <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/NCT03285035
org study id: WG2015029
nct id: NCT03285035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Cryoablation combined with chemotherapy on the quality of life of patients with non
      resectable esophageal or gastroesophageal cancer.
This is a single arm prospective study to determine the effect of cryoablation combined with
      chemotherapy on the quality of life of patients with non resectable esophageal or
      gastroesophageal cancer.
observational model: Cohort
time perspective: Prospective
measure: Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
time frame: 6 months
measure: Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline
time frame: 1 to 2 weeks
measure: Number of participants with adverse events as assessed by CTCAE 4.03.
time frame: 30 days
measure: Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting
time frame: 1 year
measure: Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.
time frame: 1 year
measure: Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined
time frame: 1 to 12 weeks
measure: Immunoassays will be obtained before and after treatment
time frame: 1 year
measure: local tumor control will be compared to systemic tumor control
time frame: 1 year
measure: Survival while on cryotherapy and systemic chemotherapy will be measured.
time frame: 1 year
measure: Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline
time frame: 1 year
arm group label: Non-operable esophageal cancer
description: Cryotherapy treatment
intervention type: Device
intervention name: Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
description: Upper endoscopy with cryotherapy using liquid nitrogen.
arm group label: Non-operable esophageal cancer
Archival tissue or fresh tissue from gastrointestinal biopsies used for diagnostic purposes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
last name: Toufic Kachaamy, MD
role: Principal Investigator
affiliation: Western Regional Medical Center
last name: Study Coordinator
phone: 623-207-3000
email: WesternTrials@ctca-hope.com
last name: Research Nurse, RN
phone: 623-207-3000
email: WesternTrials@ctca-hope.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No