<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/NCT04452357</url>
  </required_header>
  <id_info>
    <org_study_id>RT-155</org_study_id>
    <secondary_id>18-1085</secondary_id>
    <nct_id>NCT04452357</nct_id>
  </id_info>
  <brief_title>Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer</brief_title>
  <official_title>RT-155: Utilizing Pulsed Low-dose-rate (PLDR) Radiation to Prevent de Novo Stromal Activation; a Neoadjuvant Pancreatic Adenocarcinoma Phase I Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox Chase Cancer Center</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>
      Standard chemoradiation, followed by surgery are standard treatment plan for patients&#xD;
      suffering from pancreatic adenocarcinoma. Due to damage to the surrounding healthy tissue&#xD;
      caused by standard radiation, this study uses a new type of radiation plan- pulsed low-dose&#xD;
      rate (PLDR) radiation , in combination with chemotherapeutic drug, gemcitabine, given weekly&#xD;
      along with the radiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiation, combined with radiosensitizing chemotherapies, is often used preoperatively for&#xD;
      borderline resectable cases with the intent of facilitating a curative surgical intervention.&#xD;
      This includes providing margin adjacent to un-resectable vessels and sterilizing regional&#xD;
      lymph nodes. Unfortunately, due to the radiosensitivity of adjacent small bowel and stomach,&#xD;
      the total dose of radiation used is modest due to the risk of toxicities associated with&#xD;
      higher doses. Pulsed low-dose-rate (PLDR) radiation improves the safety of radiation through&#xD;
      breaking it up into small pulses. This increases the repair of DNA damage in normal tissues&#xD;
      while remaining effective in cancer cells. Multiple prior studies have shown PLDR to be safe&#xD;
      in the setting of re-irradiation, where additional radiation with conventional techniques is&#xD;
      associated with severe toxicity.&#xD;
&#xD;
      PLDR radiation will be given in 2 doses to 6 patients at each dose level:&#xD;
&#xD;
      Dose level 1: 56 Gy- given over 6 weeks Dose level 2: 66 Gy- given over 7 weeks Standard&#xD;
      chemotherapeutic drug, gemcitabine, will be administered once a week for the duration of&#xD;
      radiation.&#xD;
&#xD;
      This treatment will be followed by standard surgery to remove the cancer after consultation&#xD;
      with a surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 13, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>N/A</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>Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation.</measure>
    <time_frame>11 weeks</time_frame>
    <description>Number of participants with Grade 3 toxicity related to the treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>PLDR Chemoradiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive pulse-low-dose rate radiation, along with gemcitabine chemotherapy.&#xD;
6 patients each will be accrued at two dose levels. PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows: Dose level 1: 56 Gy; Dose level 2: 66 Gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PLDR</intervention_name>
    <description>PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows:&#xD;
Dose level 1: 56 Gy; Dose level 2: 66 Gy Drug: Gemcitabine</description>
    <arm_group_label>PLDR Chemoradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically or cytologically-confirmed pancreatic&#xD;
             adenocarcinoma.&#xD;
&#xD;
          -  Patients must have non-metastatic pancreatic cancer not appropriate for immediate&#xD;
             surgical resection. This includes the following:&#xD;
&#xD;
               -  Any involvement (defined as loss of fat plane on contrast CT) of any of the&#xD;
                  following vessels*:&#xD;
&#xD;
                    -  Common hepatic artery&#xD;
&#xD;
                    -  Superior mesenteric artery&#xD;
&#xD;
                    -  Celiac axis&#xD;
&#xD;
                    -  Superior mesenteric vein&#xD;
&#xD;
                    -  Portal vein&#xD;
&#xD;
                    -  Aorta&#xD;
&#xD;
                         -  These criteria will be judged by the operating surgeon in conjunction&#xD;
                            with a radiologist prior to enrollment.&#xD;
&#xD;
               -  Poor performance status not immediately conducive to radical surgery&#xD;
&#xD;
               -  Other clinical reasoning by the treating physicians that supports pre-operative&#xD;
                  chemoradiation&#xD;
&#xD;
          -  Patients must have evaluable disease as measured by RECIST 1.1 criteria.&#xD;
&#xD;
          -  Planned surgical resection at the time of enrollment (may be initially staged as&#xD;
             resectable, borderline resectable, or locally-advanced/unresectable).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.&#xD;
&#xD;
          -  Adequate bone marrow, hepatic, renal function.&#xD;
&#xD;
               -  ANC ³ 1,500/ml and PLT ³ 100,000/ml&#xD;
&#xD;
               -  Bilirubin less than 1.5 ULN&#xD;
&#xD;
               -  AST and ALT &lt; 3X ULN&#xD;
&#xD;
               -  Serum Creatinine &lt;1.5X ULN&#xD;
&#xD;
          -  Prior chemotherapy allowed, but not mandatory. Patients who have undergone&#xD;
             chemotherapy prior to participating in this study must have had a 2 week washout&#xD;
             period at the time of signing the consent form.&#xD;
&#xD;
          -  Women of childbearing potential must be non-pregnant (negative pregnancy test within&#xD;
             72 hours prior to registration. Postmenopausal woman must have been amenorrheic and&#xD;
             nonlactating for at least 12 months to be considered of non-childbearing potential.&#xD;
             Men and women of child bearing potential must be willing to exercise an effective form&#xD;
             of birth control (abstinence/contraception) while on study and for 3 months after&#xD;
             therapy is completed. Please refer to section 6.4 for additional detail.&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Participants must sign a written informed consent and HIPAA consent prior to&#xD;
             performance of study-specific procedures or assessments and must be willing to comply&#xD;
             with treatment and follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiological or cytologically confirmed metastatic disease&#xD;
&#xD;
          -  Patients who have had any prior therapy for pancreatic cancer, except chemotherapy&#xD;
             (see 6.1.7)&#xD;
&#xD;
          -  Concurrent non-study chemotherapy or biologic therapy&#xD;
&#xD;
          -  A history of ataxia telangiectasia or other documented history of radiation&#xD;
             hypersensitivity&#xD;
&#xD;
          -  Scleroderma or active connective tissue disease&#xD;
&#xD;
          -  Active inflammatory bowel disease&#xD;
&#xD;
          -  Serious, active infections requiring treatment with IV antibiotics&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements.&#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_contact>
    <last_name>Joshua Meyer, MD</last_name>
    <phone>215-728-2667</phone>
    <email>Joshua.Meyer@fccc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meghann Hainsworth</last_name>
    <phone>215-728-5506</phone>
    <email>Meghann.Hainsworth@fccc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Meyer, MD</last_name>
      <phone>215-728-2667</phone>
      <email>Joshua.Meyer@fccc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Meghann Hainsworth</last_name>
      <phone>215-728-5506</phone>
      <email>Meghann.Hainsworth@fccc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 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>Pancreatic Neoplasms</mesh_term>
  </condition_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/NCT04452357
org study id: RT-155
secondary id: 18-1085
nct id: NCT04452357
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Standard chemoradiation, followed by surgery are standard treatment plan for patients
      suffering from pancreatic adenocarcinoma. Due to damage to the surrounding healthy tissue
      caused by standard radiation, this study uses a new type of radiation plan- pulsed low-dose
      rate (PLDR) radiation , in combination with chemotherapeutic drug, gemcitabine, given weekly
      along with the radiation.
Radiation, combined with radiosensitizing chemotherapies, is often used preoperatively for
      borderline resectable cases with the intent of facilitating a curative surgical intervention.
      This includes providing margin adjacent to un-resectable vessels and sterilizing regional
      lymph nodes. Unfortunately, due to the radiosensitivity of adjacent small bowel and stomach,
      the total dose of radiation used is modest due to the risk of toxicities associated with
      higher doses. Pulsed low-dose-rate (PLDR) radiation improves the safety of radiation through
      breaking it up into small pulses. This increases the repair of DNA damage in normal tissues
      while remaining effective in cancer cells. Multiple prior studies have shown PLDR to be safe
      in the setting of re-irradiation, where additional radiation with conventional techniques is
      associated with severe toxicity.

      PLDR radiation will be given in 2 doses to 6 patients at each dose level:

      Dose level 1: 56 Gy- given over 6 weeks Dose level 2: 66 Gy- given over 7 weeks Standard
      chemotherapeutic drug, gemcitabine, will be administered once a week for the duration of
      radiation.

      This treatment will be followed by standard surgery to remove the cancer after consultation
      with a surgeon.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation.
time frame: 11 weeks
description: Number of participants with Grade 3 toxicity related to the treatment
arm group label: PLDR Chemoradiation
arm group type: Experimental
description: Patients will receive pulse-low-dose rate radiation, along with gemcitabine chemotherapy.
6 patients each will be accrued at two dose levels. PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows: Dose level 1: 56 Gy; Dose level 2: 66 Gy
intervention type: Radiation
intervention name: PLDR
description: PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows:
Dose level 1: 56 Gy; Dose level 2: 66 Gy Drug: Gemcitabine
arm group label: PLDR Chemoradiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua Meyer, MD
phone: 215-728-2667
email: Joshua.Meyer@fccc.edu
last name: Meghann Hainsworth
phone: 215-728-5506
email: Meghann.Hainsworth@fccc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms