<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/NCT04467021</url>
  </required_header>
  <id_info>
    <org_study_id>EAQ191</org_study_id>
    <secondary_id>NCI-2020-00900</secondary_id>
    <secondary_id>EAQ191</secondary_id>
    <secondary_id>ECOG-ACRIN-EAQ191</secondary_id>
    <secondary_id>EAQ191</secondary_id>
    <secondary_id>UG1CA189828</secondary_id>
    <nct_id>NCT04467021</nct_id>
  </id_info>
  <brief_title>Cancer and Blood Pressure Management, CARISMA Study</brief_title>
  <official_title>Cancer Therapy Risk-Reduction With Intensive Systolic BP Management (CARISMA) - a Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ECOG-ACRIN Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Cooperative Oncology Group</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well intensive blood pressure management works in decreasing&#xD;
      systolic blood pressure in patients with kidney or thyroid cancer that has spread to other&#xD;
      places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor&#xD;
      cancer therapy. This study is being done to find out if a systolic blood pressure to a target&#xD;
      of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well&#xD;
      tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg&#xD;
      while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors&#xD;
      understand the best way to control blood pressure in kidney or thyroid cancer patients taking&#xD;
      anti-angiogenic tyrosine kinase inhibitor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the feasibility of an intensive (systolic blood pressure [SBP] &lt; 120 mmHg)&#xD;
      &quot;Intervention&quot; versus standard care (SBP &lt; 140 mmHg) &quot;Non-Intervention&quot; approach to blood&#xD;
      pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating&#xD;
      anti-angiogenic tyrosine kinase inhibitors.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM A: Patients receive intensive systolic blood pressure management for 6 months. Patients&#xD;
      receive increased blood pressure medication every 2 weeks while systolic blood pressure is&#xD;
      120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1&#xD;
      day) every 2 weeks and upload the recorded blood pressure readings to the provider and to a&#xD;
      central blood pressure monitoring team. Patients with changes in blood pressure medications&#xD;
      monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).&#xD;
&#xD;
      ARM B: Patients receive standard blood pressure management for 6 months. Patients receive&#xD;
      blood pressure medications per doctor's instruction. Patients also monitor blood pressure at&#xD;
      home 1 day (4 times in 1 day) every 2 weeks and upload the recorded blood pressures to a&#xD;
      central monitoring team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 29, 2020</start_date>
  <completion_date type="Anticipated">June 29, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 29, 2024</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in systolic blood pressure (SBP) based on automated office BP measurements</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Differences in SBP over the 6- month study period between intensive BP control (intervention) versus standard care (non-intervention group) will be compared using the &quot;difference-indifference&quot; method. All mixed effects models will be estimated using generalized estimating equations (GEE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in SBP based on all automated home and office BP measurements</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Based on all automated home and office BP measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study retention rates</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will compare the study retention rates between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of automated home SBP measurements &gt; 180 mmHg or &lt; 90 mmHg or diastolic (D)BP &gt; 110 mmHg</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The frequency of orthostatic hypotension as defined by &gt; 20 mmHg decreases in office SBP with standing; or symptomatic hypotension, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) criteria, in participants in the intervention and non-intervention group arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in symptoms and health-related quality of life</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will compare the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue between the intensive SBP versus standardlcCare group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in patient-reported medication compliance</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will compare the medication compliance between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-rated adverse events associated with hypertension, hypotension and anti-hypertensive medications</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction with BP care</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The participant satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider satisfaction with BP care</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The provider satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of significant cardiovascular (CV) events</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Will determine the rates of adverse cardiovascular events in each group. These include the incidence of significant CV events including stroke, acute coronary syndrome/myocardial infarction or hospitalization for heart failure; the suspension of anti-angiogenic tyrosine kinase inhibitors therapy due to toxicity; or all-cause death.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cardiovascular Disorder</condition>
  <condition>Chronic Kidney Disease</condition>
  <condition>Metastatic Renal Cell Carcinoma</condition>
  <condition>Metastatic Thyroid Gland Medullary Carcinoma</condition>
  <condition>Stage IV Renal Cell Cancer AJCC v8</condition>
  <condition>Stage IV Thyroid Gland Medullary Carcinoma AJCC v8</condition>
  <condition>Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8</condition>
  <condition>Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8</condition>
  <condition>Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm A (intensive systolic blood pressure management)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks, and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (usual blood pressure management)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks, and upload the recorded blood pressures to a central monitoring team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Receive usual blood pressure management</description>
    <arm_group_label>Arm B (usual blood pressure management)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Pressure Measurement</intervention_name>
    <description>Undergo blood pressure measurement</description>
    <arm_group_label>Arm A (intensive systolic blood pressure management)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Management</intervention_name>
    <description>Undergo intensive systolic BP management</description>
    <arm_group_label>Arm A (intensive systolic blood pressure management)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (intensive systolic blood pressure management)</arm_group_label>
    <arm_group_label>Arm B (usual blood pressure management)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (intensive systolic blood pressure management)</arm_group_label>
    <arm_group_label>Arm B (usual blood pressure management)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Patient must have histologically or cytologically-proven advanced metastatic renal&#xD;
             cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic&#xD;
             tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib,&#xD;
             cabozantinib, lenvatinib, vandetanib, or axitinib)&#xD;
&#xD;
               -  NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then&#xD;
                  alternative non-sulfa medications can be considered in consultation with the&#xD;
                  C-BAC. Patient with a noted severe allergic reactions to medications listed in&#xD;
                  the algorithms is not necessarily excluded from this trial, as alternative&#xD;
                  medications could be considered in consultation with the C-BAC. Moreover, the&#xD;
                  patient treated with pre-existing medications that may interact with proposed BP&#xD;
                  medications is not necessarily excluded, as alternative medications exist. The&#xD;
                  clinical significance of any potential drug interactions can also be addressed&#xD;
                  with the C-BAC.&#xD;
&#xD;
          -  Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with&#xD;
             immunotherapy is also permissible&#xD;
&#xD;
          -  Patient must have either clinical cardiovascular (CV) disease or evidence of increased&#xD;
             CV risk as defined by one or more of the following:&#xD;
&#xD;
               -  Clinical CV disease (history of myocardial infarction [MI] acute coronary&#xD;
                  syndrome, coronary revascularization, carotid endarterectomy or stenting greater&#xD;
                  than 3 months prior to registration, peripheral artery disease, cerebrovascular&#xD;
                  accident greater than 3 months prior to registration, abdominal aortic aneurysm&#xD;
                  or heart failure [HF])&#xD;
&#xD;
               -  An American College of Cardiology/American Heart Association (ACC/AHA) CV risk&#xD;
                  score of at least 10%&#xD;
&#xD;
               -  Chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR]&#xD;
                  between 30 and 60 ml/min per 1.73 m^2). Dialysis patients and patients with an&#xD;
                  eGFR &lt; 30 ml/min/1.73m^2 will be excluded. eGFR will be calculated according to&#xD;
                  the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation&#xD;
&#xD;
          -  Patient must have systolic blood pressure (SBP) &gt;= 130 mmHg on two or more occasions&#xD;
             according to any in-clinic visit in the 12 weeks prior to or during their initial 4&#xD;
             weeks of treatment with an AA-TKI. Patient who have a prior diagnosis of hypertension&#xD;
             or on pre-existing anti-hypertensive medications are eligible for enrollment. However,&#xD;
             patient must not be on more than 3 baseline blood pressure medications at time of&#xD;
             entry&#xD;
&#xD;
               -  NOTE: If a patient has a single elevated SBP &gt;= 130mmHg but not on repeat&#xD;
                  assessment, an additional SBP assessment should be performed to confirm&#xD;
                  ineligibility&#xD;
&#xD;
          -  Patient must agree to comply with performing home blood pressure monitoring using an&#xD;
             Omron7250 oscillometric monitor at home, or equivalent models&#xD;
&#xD;
          -  Women of childbearing potential and sexually active males must be strongly advised to&#xD;
             use accepted and effective methods of contraception or to abstain from sexual&#xD;
             intercourse for the duration of their participation in the study&#xD;
&#xD;
          -  Patient must have internet access through a computer, tablet, or smart phone to use&#xD;
             EASEE-PRO and home BP monitoring. A valid phone number to receive text messages and&#xD;
             email address are also necessary&#xD;
&#xD;
          -  Leukocytes &gt;= 3,000/mcL (obtained within 14 days prior to registration)&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,500/mcL (obtained within 14 days prior to registration)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL (obtained within 14 days prior to registration)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to&#xD;
             registration)&#xD;
&#xD;
          -  Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral&#xD;
             load must be undetectable on suppressive therapy, if indicated&#xD;
&#xD;
          -  Patient with a history of hepatitis C virus (HCV) infection must have been treated and&#xD;
             cured. For patients with HCV infection who are currently on treatment, they are&#xD;
             eligible if they have an undetectable HCV viral load&#xD;
&#xD;
          -  Patient with treated brain metastases are eligible if follow-up brain imaging after&#xD;
             central nervous system (CNS)-directed therapy shows no evidence of progression&#xD;
&#xD;
          -  Patient with new or progressive brain metastases (active brain metastases) or&#xD;
             leptomeningeal disease are eligible if the treating physician determines that&#xD;
             immediate CNS specific treatment is not required and is unlikely to be required during&#xD;
             the first cycle of therapy&#xD;
&#xD;
          -  Patient with a prior or concurrent malignancy whose natural history or treatment does&#xD;
             not have the potential to interfere with the safety or efficacy assessment of the&#xD;
             investigational regimen are eligible for this trial&#xD;
&#xD;
          -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient must not have end-stage renal failure on dialysis, history of repeated&#xD;
             hyperkalemia with a potassium &gt; 5.5 mEq/l, or have a kidney transplant, or an eGFR &lt;&#xD;
             30 ml/min/1.73 m^2&#xD;
&#xD;
          -  Patient must not have coronary artery bypass grafting, MI acute coronary syndrome&#xD;
             severe/unstable angina, stroke, transient ischemic attack, clinically significant&#xD;
             bleeding requiring hospitalization or pulmonary embolism within 3 months prior to&#xD;
             registration&#xD;
&#xD;
          -  Patient must not have brain surgery or radiotherapy within 2 weeks prior to&#xD;
             registration&#xD;
&#xD;
          -  Patient must not have uncontrolled blood pressure defined by SBP &gt; 160 mmHg on three&#xD;
             or more antihypertensives prior to TKI initiation&#xD;
&#xD;
          -  Patient with an arm circumference too large (&gt; 50 cm) or small (&lt; 17 cm) to allow&#xD;
             accurate BP measurement with available devices will not be eligible&#xD;
&#xD;
          -  Women must not be pregnant or breast-feeding due to the potential harm to an unborn&#xD;
             fetus and possible risk for adverse events in nursing infants with some&#xD;
             anti-hypertensives, including angiotensin receptor blockers. All females of&#xD;
             childbearing potential must have a blood test or urine study within 14 days prior to&#xD;
             registration to rule out pregnancy. A female of childbearing potential is defined as&#xD;
             any woman, regardless of sexual orientation or whether they have undergone tubal&#xD;
             ligation, who meets the following criteria: has achieved menarche at some point, has&#xD;
             not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally&#xD;
             postmenopausal (amenorrhea following cancer therapy does not rule out childbearing&#xD;
             potential) for at least 24 consecutive months (i.e., has had menses at any time in the&#xD;
             preceding 24 consecutive months)&#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>Bonnie Ky</last_name>
    <role>Principal Investigator</role>
    <affiliation>ECOG-ACRIN Cancer Research Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bonnie Ky</last_name>
    <phone>215-573-6606</phone>
    <email>bonnie.ky@pennmedicine.upenn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Joshua D. Mitchell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Joshua D. Mitchell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center-Einstein Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Gartrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center-Weiler Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Gartrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Gartrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania/Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-474-9892</phone>
    </contact>
    <investigator>
      <last_name>Bonnie Ky</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-647-8073</phone>
    </contact>
    <investigator>
      <last_name>Leonard J. Appleman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Vlad G. Zaha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Southern Lakes VLCC</name>
      <address>
        <city>Burlington</city>
        <state>Wisconsin</state>
        <zip>53105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Saint Luke's South Shore</name>
      <address>
        <city>Cudahy</city>
        <state>Wisconsin</state>
        <zip>53110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Health Care Germantown Health Center</name>
      <address>
        <city>Germantown</city>
        <state>Wisconsin</state>
        <zip>53022</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Grafton</name>
      <address>
        <city>Grafton</city>
        <state>Wisconsin</state>
        <zip>53024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora BayCare Medical Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54311</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Kenosha South</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53142</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Bay Area Medical Group-Marinette</name>
      <address>
        <city>Marinette</city>
        <state>Wisconsin</state>
        <zip>54143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Milwaukee</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Saint Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Sinai Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vince Lombardi Cancer Clinic - Oshkosh</name>
      <address>
        <city>Oshkosh</city>
        <state>Wisconsin</state>
        <zip>54904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Racine</name>
      <address>
        <city>Racine</city>
        <state>Wisconsin</state>
        <zip>53406</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vince Lombardi Cancer Clinic-Sheboygan</name>
      <address>
        <city>Sheboygan</city>
        <state>Wisconsin</state>
        <zip>53081</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Medical Center in Summit</name>
      <address>
        <city>Summit</city>
        <state>Wisconsin</state>
        <zip>53066</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vince Lombardi Cancer Clinic-Two Rivers</name>
      <address>
        <city>Two Rivers</city>
        <state>Wisconsin</state>
        <zip>54241</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer Care-Milwaukee West</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aurora West Allis Medical Center</name>
      <address>
        <city>West Allis</city>
        <state>Wisconsin</state>
        <zip>53227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-302-2304</phone>
      <email>ncorp@aurora.org</email>
    </contact>
    <investigator>
      <last_name>Rubina Qamar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Carcinoma, Medullary</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT04467021
org study id: EAQ191
secondary id: NCI-2020-00900
secondary id: EAQ191
secondary id: ECOG-ACRIN-EAQ191
secondary id: EAQ191
secondary id: UG1CA189828
nct id: NCT04467021
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This phase II trial studies how well intensive blood pressure management works in decreasing
      systolic blood pressure in patients with kidney or thyroid cancer that has spread to other
      places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor
      cancer therapy. This study is being done to find out if a systolic blood pressure to a target
      of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well
      tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg
      while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors
      understand the best way to control blood pressure in kidney or thyroid cancer patients taking
      anti-angiogenic tyrosine kinase inhibitor.
PRIMARY OBJECTIVE:

      I. To determine the feasibility of an intensive (systolic blood pressure [SBP] < 120 mmHg)
      "Intervention" versus standard care (SBP < 140 mmHg) "Non-Intervention" approach to blood
      pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating
      anti-angiogenic tyrosine kinase inhibitors.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM A: Patients receive intensive systolic blood pressure management for 6 months. Patients
      receive increased blood pressure medication every 2 weeks while systolic blood pressure is
      120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1
      day) every 2 weeks and upload the recorded blood pressure readings to the provider and to a
      central blood pressure monitoring team. Patients with changes in blood pressure medications
      monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).

      ARM B: Patients receive standard blood pressure management for 6 months. Patients receive
      blood pressure medications per doctor's instruction. Patients also monitor blood pressure at
      home 1 day (4 times in 1 day) every 2 weeks and upload the recorded blood pressures to a
      central monitoring team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Differences in systolic blood pressure (SBP) based on automated office BP measurements
time frame: Up to 6 months
description: Differences in SBP over the 6- month study period between intensive BP control (intervention) versus standard care (non-intervention group) will be compared using the "difference-indifference" method. All mixed effects models will be estimated using generalized estimating equations (GEE).
measure: Difference in SBP based on all automated home and office BP measurements
time frame: Up to 6 months
description: Based on all automated home and office BP measurements.
measure: Study retention rates
time frame: Up to 6 months
description: Will compare the study retention rates between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation
measure: Frequency of automated home SBP measurements > 180 mmHg or < 90 mmHg or diastolic (D)BP > 110 mmHg
time frame: Up to 6 months
description: The frequency of orthostatic hypotension as defined by > 20 mmHg decreases in office SBP with standing; or symptomatic hypotension, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) criteria, in participants in the intervention and non-intervention group arms.
measure: Differences in symptoms and health-related quality of life
time frame: Up to 6 months
description: Will compare the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue between the intensive SBP versus standardlcCare group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.
measure: Differences in patient-reported medication compliance
time frame: Up to 6 months
description: Will compare the medication compliance between the intensive SBP versus standard care group, by constructing appropriate mixed-effect generalized linear models (e.g. a mixed effect log-linear model for fatigue and a logistic model for study retention) and using GEE for model estimation.
measure: Patient-rated adverse events associated with hypertension, hypotension and anti-hypertensive medications
time frame: Up to 6 months
measure: Participant satisfaction with BP care
time frame: Up to 6 months
description: The participant satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.
measure: Provider satisfaction with BP care
time frame: Up to 6 months
description: The provider satisfaction with BP care (including the C-BAC and the related technologies) and BP medications will be evaluated through questionnaires evaluated on a Likert scale and via open ended discussions with focus groups.
measure: Incidence of significant cardiovascular (CV) events
time frame: Up to 6 months
description: Will determine the rates of adverse cardiovascular events in each group. These include the incidence of significant CV events including stroke, acute coronary syndrome/myocardial infarction or hospitalization for heart failure; the suspension of anti-angiogenic tyrosine kinase inhibitors therapy due to toxicity; or all-cause death.
arm group label: Arm A (intensive systolic blood pressure management)
arm group type: Experimental
description: Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks, and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).
arm group label: Arm B (usual blood pressure management)
arm group type: Active Comparator
description: Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks, and upload the recorded blood pressures to a central monitoring team.
intervention type: Other
intervention name: Best Practice
description: Receive usual blood pressure management
arm group label: Arm B (usual blood pressure management)
other name: standard of care
other name: standard therapy
intervention type: Other
intervention name: Blood Pressure Measurement
description: Undergo blood pressure measurement
arm group label: Arm A (intensive systolic blood pressure management)
intervention type: Other
intervention name: Clinical Management
description: Undergo intensive systolic BP management
arm group label: Arm A (intensive systolic blood pressure management)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm A (intensive systolic blood pressure management)
arm group label: Arm B (usual blood pressure management)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (intensive systolic blood pressure management)
arm group label: Arm B (usual blood pressure management)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bonnie Ky
role: Principal Investigator
affiliation: ECOG-ACRIN Cancer Research Group
last name: Bonnie Ky
phone: 215-573-6606
email: bonnie.ky@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Carcinoma, Medullary
mesh term: Thyroid Neoplasms
mesh term: Carcinoma, Neuroendocrine
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Cardiovascular Diseases
mesh term: Thyroid Diseases