<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/NCT02241499</url>
  </required_header>
  <id_info>
    <org_study_id>DBG01</org_study_id>
    <nct_id>NCT02241499</nct_id>
  </id_info>
  <brief_title>Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.</brief_title>
  <acronym>PALAESTRA</acronym>
  <official_title>Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial, patients with histologically proven adenocarcinoma of the esophagus or&#xD;
      esophagogastric junction noneligible for surgery or chemoradiation with curative intent will&#xD;
      be included. Primary objective is to determine the rate of improvement in dysphagia after&#xD;
      palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy&#xD;
      consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated&#xD;
      by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be&#xD;
      an improvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>Phase 2</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>Improvement of dysphagia.</measure>
    <time_frame>The grade of dysphagia is evaluated before start of treatment, 1-4 weeks after end of radiotherapy, then until local intervention or death, average of 12 months.</time_frame>
    <description>The rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an approvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endoscopic response of the primary tumor.</measure>
    <time_frame>Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Metabolic response</measure>
    <time_frame>Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy.</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Adenocarcinoma of the Esophagus or Esophagogastric Junction</condition>
  <arm_group>
    <arm_group_label>Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation therapy</intervention_name>
    <description>Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.</description>
    <arm_group_label>Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin and fluorouracil.</intervention_name>
    <description>Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days.</description>
    <arm_group_label>Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric&#xD;
             junction noneligible for surgery or chemoradiation with curative intent&#xD;
&#xD;
          -  Any T, N and M&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
          -  WHO performance status ≤ 2&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  Dysphagia score &gt; 0&#xD;
&#xD;
          -  Adequate laboratory findings: hemoglobin &gt; 90 g/L, absolute neutrophil count&#xD;
&#xD;
               -  1.0 10 9/L, platelets ≥ 75 x 10 9/L, bilirubin ≤ 1.5 x upper limit of normal&#xD;
                  (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN, creatinine ≤ 1.5 x ULN&#xD;
&#xD;
          -  Fertile men and women must use effective means of contraception&#xD;
&#xD;
          -  Signed written informed concent&#xD;
&#xD;
          -  The patient must be able to comply with the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy&#xD;
             for the present disease&#xD;
&#xD;
          -  Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction&#xD;
             (≤ 6 months) unstable angina, New York Heart Association (NYHA) grade III-IV&#xD;
             congestive heart failure&#xD;
&#xD;
          -  Severe pulmonary disease e.g. pulmonary fibrosis&#xD;
&#xD;
          -  Symptomatic peripheral neuropathy greater than grade 1 (CTCAE v. 4.0)&#xD;
&#xD;
          -  Known hypersensitivity to any contents of the study drugs&#xD;
&#xD;
          -  Pregnancy ( positive pregnancy test) and/or breast feeding&#xD;
&#xD;
          -  Any other serious or uncontrolled illness which in the opinion of the investigator&#xD;
             makes it undesirable for the patient to enter 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>David Borg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University Hospital, Department of Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lund University Hospital, Department of Oncology</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Digestive System Diseases</keyword>
  <keyword>Esophageal cancer</keyword>
  <keyword>Intestinal Neoplasms</keyword>
  <keyword>Gastrointestinal Neoplasms</keyword>
  <keyword>Digestive System Neoplasms</keyword>
  <keyword>Endoscopic response</keyword>
  <keyword>Fluorouracil</keyword>
  <keyword>Metabolic response</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</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/NCT02241499
org study id: DBG01
nct id: NCT02241499
lead sponsor: 
has dmc: No
In this trial, patients with histologically proven adenocarcinoma of the esophagus or
      esophagogastric junction noneligible for surgery or chemoradiation with curative intent will
      be included. Primary objective is to determine the rate of improvement in dysphagia after
      palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy
      consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated
      by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be
      an improvement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement of dysphagia.
time frame: The grade of dysphagia is evaluated before start of treatment, 1-4 weeks after end of radiotherapy, then until local intervention or death, average of 12 months.
description: The rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an approvement.
measure: Endoscopic response of the primary tumor.
time frame: Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.
measure: Metabolic response
time frame: Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy.
arm group label: Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
arm group type: Experimental
description: Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2.
intervention type: Radiation
intervention name: Radiation therapy
description: Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.
arm group label: Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
intervention type: Drug
intervention name: Oxaliplatin and fluorouracil.
description: Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days.
arm group label: Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Borg, MD
role: Principal Investigator
affiliation: Lund University Hospital, Department of Oncology
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Fluorouracil
mesh term: Oxaliplatin