xml: <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/NCT06040801</url>
    </required_header>
    <id_info>
      <org_study_id>202002181B0A3</org_study_id>
      <secondary_id>CMRPG3L1611</secondary_id>
      <nct_id>NCT06040801</nct_id>
    </id_info>
    <brief_title>Effect of Geriatric Intervention in Frail Patients With Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy</brief_title>
    <official_title>Effect of Geriatric Intervention in Frail Patients With Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chang Gung Memorial Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Gastric, biliary and pancreatic cancer are commonly malignancies from gastro- intestinal&#xD;
        tract in Taiwan. Because lack of specific symptoms at presentation and effective screening&#xD;
        methodology, majority of these patients are diagnosed with metastatic or unresectable&#xD;
        disease. Palliative chemotherapy is the good standard of therapy for patients with&#xD;
        unresectable gastric, biliary and pancreatic cancer with benefit of prolong survival time and&#xD;
        improve quality of life.&#xD;
  &#xD;
        Although the benefit of palliative chemotherapy seems to be the same for elderly and young&#xD;
        cancer patients in clinical study, elderly patients are less frequently treated with&#xD;
        chemotherapy or treated with suboptimal dosage. Elderly patients do not receive palliative&#xD;
        chemotherapy because concerns of elder age, comorbidity, poor performance, lack of&#xD;
        social/economic support and worry about treatment toxicities.&#xD;
  &#xD;
        The increase in life expectancy of the general population resulted in an increase in the&#xD;
        number of elderly patients with cancers referred for palliative chemotherapy. Overtreatment&#xD;
        may result in high mortality due to disregard of the aging patients' frailty; on the other&#xD;
        hand, under-treatment resulting from over-concern regarding their ability to tolerate&#xD;
        treatment, may compromise the survival outcome. Therefore, the appropriately selection of&#xD;
        geriatric cancer patients for palliative chemotherapy has to be addressed urgently.&#xD;
  &#xD;
        Frailty is a progressive decline of physiological reserve leading to multiple functional&#xD;
        disability and increases vulnerability to subsequent morbidity and mortality. Frailty is&#xD;
        associated with treatment toxicity, chemotherapy tolerance, and survival outcome in clinical&#xD;
        oncology. Recent randomized study reported geriatric intervention significantly improved&#xD;
        chemotherapy tolerance in elderly patients. Therefore, the American Cancer Association has&#xD;
        recommended routine geriatric assessment and intervention in oncogeriatric patients upon&#xD;
        providing antitumor treatments. However, the effect of geriatric intervention on chemotherapy&#xD;
        tolerance is seldom in Taiwan.&#xD;
  &#xD;
        This study is an open, randomized, prospective trial to evaluate the effect of geriatric&#xD;
        intervention on chemotherapy tolerance in patients with unresectable gastric, biliary, and&#xD;
        pancreatic cancer. All patients with receive frailty assessment within 7 days before&#xD;
        initiation of first cycle palliative chemotherapy followed by geriatric intervention. The&#xD;
        study aim is to compare for chemotherapy tolerance, treatment-related toxicity, and quality&#xD;
        of life after completion 3 months chemotherapy treatment course between frail and non-frail&#xD;
        patients. This study also aims to explore the effect of geriatric intervention of treatment&#xD;
        tolerance, treatment-related toxicity, and quality of life in frail patients with gastric,&#xD;
        biliary, and pancreatic cancer receiving palliative chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <phase>N/A</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Examine the completion rate of chemotherapy in frail and non-frail patient groups three months after treatment initiation to assess whether frailty affects tolerance.</measure>
      <time_frame>After completion 3 months chemotherapy treatment.</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two.</measure>
      <time_frame>After completion 3 months chemotherapy treatment.</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Assess the level of quality of life in frail and non-frail patient groups before and after treatment using a frailty questionnaire.</measure>
      <time_frame>After completion 3 months chemotherapy treatment.</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>GI Cancer</condition>
    <arm_group>
      <arm_group_label>Frail group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-frail group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Frailty intervention measures</intervention_name>
      <description>Providing management and recommendations based on the specific impairment domain.&#xD;
  Assessment domain:&#xD;
  Physical function&#xD;
  Nutrition&#xD;
  Social support&#xD;
  Cognition&#xD;
  Polypharmacy and Comorbidity&#xD;
  Psychological</description>
      <arm_group_label>Frail group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged sixty-five or older with metastatic or unresectable gastric, biliary,&#xD;
               and pancreatic cancer.&#xD;
  &#xD;
            -  The patient must sign the informed consent form.&#xD;
  &#xD;
            -  Estimated survival period of more than 3 months.&#xD;
  &#xD;
            -  Conscious and able to communicate verbally or in writing, and willing to cooperate&#xD;
               with invasive procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with cognitive impairment or unable to cooperate with the interventional&#xD;
               procedures as determined by the clinical physician.&#xD;
  &#xD;
            -  Patients receiving concurrent other anticancer treatments (radiation or surgery).&#xD;
  &#xD;
            -  Patients with multiple types of cancer requiring simultaneous treatment.&#xD;
  &#xD;
            -  Patients who have previously participated in this study during a prior chemotherapy&#xD;
               regimen.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wen-Chi Chou, M.D.</last_name>
      <phone>+886328-1200</phone>
      <phone_ext>8426</phone_ext>
      <email>f12986@cgmh.org.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chang Gung Memorial Hospital</name>
        <address>
          <city>Taoyuan</city>
          <zip>330</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wen-Chi Chou</last_name>
        <phone>+8863281200</phone>
        <phone_ext>8426</phone_ext>
        <email>f12986@cgmh.org.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Frailty</keyword>
    <keyword>Comprehensive Geriatric Assessment (CGA)</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Outcome</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040801
  org study id: 202002181B0A3
  secondary id: CMRPG3L1611
  nct id: NCT06040801
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Gastric, biliary and pancreatic cancer are commonly malignancies from gastro- intestinal
        tract in Taiwan. Because lack of specific symptoms at presentation and effective screening
        methodology, majority of these patients are diagnosed with metastatic or unresectable
        disease. Palliative chemotherapy is the good standard of therapy for patients with
        unresectable gastric, biliary and pancreatic cancer with benefit of prolong survival time and
        improve quality of life.
  
        Although the benefit of palliative chemotherapy seems to be the same for elderly and young
        cancer patients in clinical study, elderly patients are less frequently treated with
        chemotherapy or treated with suboptimal dosage. Elderly patients do not receive palliative
        chemotherapy because concerns of elder age, comorbidity, poor performance, lack of
        social/economic support and worry about treatment toxicities.
  
        The increase in life expectancy of the general population resulted in an increase in the
        number of elderly patients with cancers referred for palliative chemotherapy. Overtreatment
        may result in high mortality due to disregard of the aging patients' frailty; on the other
        hand, under-treatment resulting from over-concern regarding their ability to tolerate
        treatment, may compromise the survival outcome. Therefore, the appropriately selection of
        geriatric cancer patients for palliative chemotherapy has to be addressed urgently.
  
        Frailty is a progressive decline of physiological reserve leading to multiple functional
        disability and increases vulnerability to subsequent morbidity and mortality. Frailty is
        associated with treatment toxicity, chemotherapy tolerance, and survival outcome in clinical
        oncology. Recent randomized study reported geriatric intervention significantly improved
        chemotherapy tolerance in elderly patients. Therefore, the American Cancer Association has
        recommended routine geriatric assessment and intervention in oncogeriatric patients upon
        providing antitumor treatments. However, the effect of geriatric intervention on chemotherapy
        tolerance is seldom in Taiwan.
  
        This study is an open, randomized, prospective trial to evaluate the effect of geriatric
        intervention on chemotherapy tolerance in patients with unresectable gastric, biliary, and
        pancreatic cancer. All patients with receive frailty assessment within 7 days before
        initiation of first cycle palliative chemotherapy followed by geriatric intervention. The
        study aim is to compare for chemotherapy tolerance, treatment-related toxicity, and quality
        of life after completion 3 months chemotherapy treatment course between frail and non-frail
        patients. This study also aims to explore the effect of geriatric intervention of treatment
        tolerance, treatment-related toxicity, and quality of life in frail patients with gastric,
        biliary, and pancreatic cancer receiving palliative chemotherapy.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Examine the completion rate of chemotherapy in frail and non-frail patient groups three months after treatment initiation to assess whether frailty affects tolerance.
  time frame: After completion 3 months chemotherapy treatment.
  measure: Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two.
  time frame: After completion 3 months chemotherapy treatment.
  measure: Assess the level of quality of life in frail and non-frail patient groups before and after treatment using a frailty questionnaire.
  time frame: After completion 3 months chemotherapy treatment.
  arm group label: Frail group
  arm group type: Experimental
  description: All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain.
  arm group label: Non-frail group
  arm group type: No Intervention
  description: All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition.
  intervention type: Behavioral
  intervention name: Frailty intervention measures
  description: Providing management and recommendations based on the specific impairment domain.
  Assessment domain:
  Physical function
  Nutrition
  Social support
  Cognition
  Polypharmacy and Comorbidity
  Psychological
  arm group label: Frail group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wen-Chi Chou, M.D.
  phone: +886328-1200
  phone ext: 8426
  email: f12986@cgmh.org.tw
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor