<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/NCT03251365</url>
  </required_header>
  <id_info>
    <org_study_id>Pancreathipec 1.0</org_study_id>
    <secondary_id>2016-004298-41</secondary_id>
    <nct_id>NCT03251365</nct_id>
  </id_info>
  <brief_title>Intrabdominal Hyperthermic Chemotherapy and Pancreatic Cancer</brief_title>
  <official_title>Intrabdominal Hyperthermic Chemotherapy Using Gemcitabine to Treat Pancreatic Carcinomatosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General de Ciudad Real</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General de Ciudad Real</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the&#xD;
      incorporation of other centers that would increase the power of the obtained results . Our&#xD;
      hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with&#xD;
      gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer&#xD;
      by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells,&#xD;
      improving the survival of patients with pancreatic cancer, and decreasing the recurrence of&#xD;
      the disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the incidence in the area of the University General Hospital, Ciudad Real,&#xD;
      HGUCR, authors will include a population of 42 patients, n = 21 in each group, I and II, with&#xD;
      diagnosis of adenocarcinoma of the pancreas, which will be surgically resected with curative&#xD;
      intention, in the next two years, 2017-2018, with extended follow-up for at least two years&#xD;
      more for survival study Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral&#xD;
      contrast, 21 subjects were required in the first group and 21 participants in the second&#xD;
      Group to detect as statistically significant difference between two proportions, for group I&#xD;
      is expected to be 0.05 and for Group II 0.4, in relation to survival in five years. It has&#xD;
      been estimated a rate of loss of patients of 10%&#xD;
&#xD;
        -  Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient&#xD;
           after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000&#xD;
           mg / m2 for at least 4 cycles&#xD;
&#xD;
        -  Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg /&#xD;
           m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles&#xD;
           The aim is identifying morbidity and mortality associated to treatment by cytoreductive&#xD;
           surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a&#xD;
           conventional treatment group that includes cytoreductive surgery with systemic&#xD;
           chemotherapy, Group I,and identifying survival of the experimental Group with treatment&#xD;
           with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional&#xD;
           treatment group,GI&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Characteristics of the Trial: This is a randomized,interventional, multidisciplinary study,phase II-III, involving several Services as General Surgery, Pathology, Oncology, Pharmacy, Gastroenterology and Radiology at the University General Hospital of Ciudad Real and the Faculty of Medicine, and Translational Research Unit,HGUCR.The study is opened to the incorporation of other centers that increase the power of the obtained results.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>After explaining the treatment to develop once informed of the characteristics of pancreatic cancer to the patient, we will explain in detail the clinical trial that we are going to develop. After obtaining the informed consent, authors will start the randomly distribution of patients A list of randomization to 42 patients will be developed by a computer program that simulates the extraction procedure of numbered balls and the correlative allocation to each of the codes.&#xD;
Randomization is by block, thereby ensuring a balanced number of subjects per treatment. Then a scrambling code in which randomly assigned treatment to each code will be developed.&#xD;
The randomization code and study randomization list shall be kept only for the person that will carry the allocation of treatments.Randomization of patients will be performed centrally. Each patient is assigned to a sequential number of the centralized list of inclusion and appropriate treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>• Identify morbidity associated to treatment by cytoreductive surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a conventional treatment group that includes cytoreductive surgery with systemic chemotherapy, Group I</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>18 months</time_frame>
    <description>• Identify survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Resectable Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Group I, Normal</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II,experimental.HIPEC-Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HIPEC-gemcitabine</intervention_name>
    <description>• Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles</description>
    <arm_group_label>Group II,experimental.HIPEC-Gemcitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        · Resectable pancreatic adenocarcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Voluntary refusal to participate in the trial&#xD;
&#xD;
          -  Existence of distant disease that contraindicates the surgical treatment&#xD;
&#xD;
          -  Patients with preoperative or intraoperative locoregional unresectable pancreatic&#xD;
             cancer&#xD;
&#xD;
          -  Existence of synchronous neoplastic disease&#xD;
&#xD;
          -  Exclusion after perioperative anesthetic study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>David Padilla-Valverde, MD,PhD</last_name>
    <phone>34926278000</phone>
    <phone_ext>79784</phone_ext>
    <email>Davidp@sescam.jccm.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario de Ciudad Real, HGUCR</name>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Javier Redondo-Calvo, MD,PhD</last_name>
      <phone>34926278000</phone>
      <phone_ext>79784</phone_ext>
      <email>ardredondo@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 13, 2017</last_update_submitted>
  <last_update_submitted_qc>August 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General de Ciudad Real</investigator_affiliation>
    <investigator_full_name>David Padilla-Valverde</investigator_full_name>
    <investigator_title>Chief of Hepatobiliary Unit, Department of Surgery,HGUCR.Coordinator of Research Traslational Unit,HGUCR.Professor of Surgery, Faculty of Medicine, UCLM, Ciudad Real, Spain</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Pancreatic carcinomatosis</keyword>
  <keyword>Intrabdominal hyperthermic chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</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/NCT03251365
org study id: Pancreathipec 1.0
secondary id: 2016-004298-41
nct id: NCT03251365
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized, multidisciplinary study, Phase II-III clinical trial.The study is opened to the
      incorporation of other centers that would increase the power of the obtained results . Our
      hypothesis considers that using Hyperthermic Intra-abdominal Chemotherapy,HIPEC, with
      gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer
      by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells,
      improving the survival of patients with pancreatic cancer, and decreasing the recurrence of
      the disease
According to the incidence in the area of the University General Hospital, Ciudad Real,
      HGUCR, authors will include a population of 42 patients, n = 21 in each group, I and II, with
      diagnosis of adenocarcinoma of the pancreas, which will be surgically resected with curative
      intention, in the next two years, 2017-2018, with extended follow-up for at least two years
      more for survival study Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral
      contrast, 21 subjects were required in the first group and 21 participants in the second
      Group to detect as statistically significant difference between two proportions, for group I
      is expected to be 0.05 and for Group II 0.4, in relation to survival in five years. It has
      been estimated a rate of loss of patients of 10%

        -  Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient
           after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000
           mg / m2 for at least 4 cycles

        -  Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg /
           m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
           The aim is identifying morbidity and mortality associated to treatment by cytoreductive
           surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a
           conventional treatment group that includes cytoreductive surgery with systemic
           chemotherapy, Group I,and identifying survival of the experimental Group with treatment
           with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional
           treatment group,GI
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Characteristics of the Trial: This is a randomized,interventional, multidisciplinary study,phase II-III, involving several Services as General Surgery, Pathology, Oncology, Pharmacy, Gastroenterology and Radiology at the University General Hospital of Ciudad Real and the Faculty of Medicine, and Translational Research Unit,HGUCR.The study is opened to the incorporation of other centers that increase the power of the obtained results.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: After explaining the treatment to develop once informed of the characteristics of pancreatic cancer to the patient, we will explain in detail the clinical trial that we are going to develop. After obtaining the informed consent, authors will start the randomly distribution of patients A list of randomization to 42 patients will be developed by a computer program that simulates the extraction procedure of numbered balls and the correlative allocation to each of the codes.
Randomization is by block, thereby ensuring a balanced number of subjects per treatment. Then a scrambling code in which randomly assigned treatment to each code will be developed.
The randomization code and study randomization list shall be kept only for the person that will carry the allocation of treatments.Randomization of patients will be performed centrally. Each patient is assigned to a sequential number of the centralized list of inclusion and appropriate treatment.
measure: Morbidity
time frame: 30 days
description: • Identify morbidity associated to treatment by cytoreductive surgery and HIPEC with gemcitabine+ systemic chemotherapy,Group II, respect to a conventional treatment group that includes cytoreductive surgery with systemic chemotherapy, Group I
measure: Survival
time frame: 18 months
description: • Identify survival of the experimental Group with treatment with cytoreductive surgery and HIPEC with gemcitabine ,respect to the conventional treatment group,GI
arm group label: Group I, Normal
arm group type: No Intervention
description: Group I. After cytoreductive surgery, R0, and intestinal reconstruction, the patient after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
arm group label: Group II,experimental.HIPEC-Gemcitabine
arm group type: Experimental
description: • Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
intervention type: Drug
intervention name: HIPEC-gemcitabine
description: • Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
arm group label: Group II,experimental.HIPEC-Gemcitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Padilla-Valverde, MD,PhD
phone: 34926278000
phone ext: 79784
email: Davidp@sescam.jccm.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General de Ciudad Real
investigator full name: David Padilla-Valverde
investigator title: Chief of Hepatobiliary Unit, Department of Surgery,HGUCR.Coordinator of Research Traslational Unit,HGUCR.Professor of Surgery, Faculty of Medicine, UCLM, Ciudad Real, Spain
mesh term: Hyperthermia
mesh term: Fever
mesh term: Gemcitabine
sharing ipd: Undecided