<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/NCT04495894</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000205</org_study_id>
    <nct_id>NCT04495894</nct_id>
  </id_info>
  <brief_title>Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma</brief_title>
  <official_title>A Pilot Study of Biomarker Evaluation and Safety of Pre-Incisional Ketorolac for Patients Undergoing Surgical Resection for Non-Small Cell Lung Cancer and Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study of biomarker evaluation and safety of pre-incisional ketorolac for&#xD;
      patients undergoing surgical resection for non-small cell lung cancer and renal cell&#xD;
      carcinoma. There is significant promise in the use of preoperative ketorolac to decrease the&#xD;
      inflammatory response after surgical resection of tumors, thereby potentially reducing the&#xD;
      risk of distant metastatic tumor spread and improving survival. A total of 56 patients (28&#xD;
      per disease site) will be enrolled into the experimental arm and will receive ketorolac prior&#xD;
      to surgery. About 10 patients will be allocated randomly into a control group, for each&#xD;
      disease site, for a total of 76 patients enrolled. The research will advance scientific&#xD;
      knowledge by studying the safety of a preoperative dose of ketorolac prior to major surgical&#xD;
      resection, which needs to be assessed prior to proceeding with a larger phase II study&#xD;
      designed to evaluate traditional efficacy endpoints such as recurrence and overall survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical resection is a cornerstone of standard-of-care treatment for early-stage non-small&#xD;
      cell lung carcinoma (NSCLC) and renal cell carcinoma (RCC). Yet despite optimal treatment,&#xD;
      many of these patients will develop cancer recurrence within the first few years. For&#xD;
      example, the 5-year survival rate for patients with stage I/II NSCLC is only around 55%. As a&#xD;
      result, more effective treatments that decrease cancer recurrence and increase survival are&#xD;
      still needed.&#xD;
&#xD;
      Surgery induces inflammation, immunosuppression and angiogenesis. Although these processes&#xD;
      are important for wound healing in response to tissue injury caused by surgery, they also&#xD;
      support the survival, growth and dissemination of any remaining cancer cells and can lead to&#xD;
      systemic recurrence soon after surgery. Surgical trauma increases the production of&#xD;
      prostaglandins and thromboxanes, which have tumor-promoting and immunosuppressive activities,&#xD;
      and reduces the activity of natural killer cells, which impairs the ability of the immune&#xD;
      system to keep cancer cells in check. However, if given just before tissue injury,&#xD;
      non-steroidal anti-inflammatory drugs (NSAIDs) may be able to block the production of&#xD;
      prostaglandins/thromboxanes and boost the activity of natural killer cells, and thereby&#xD;
      decrease the risk of cancer recurrence. NSAIDs such as ketorolac are already routinely given&#xD;
      to cancer patients postoperatively for pain management and are sometimes given&#xD;
      intraoperatively (immediately before or during surgery) to prevent postoperative pain. A&#xD;
      retrospective clinical analysis found that intraoperative intravenous ketorolac or diclofenac&#xD;
      (another NSAID), when added to standard of care for patients with stage I/II NSCLC, was&#xD;
      associated with decreased risks of distant recurrence and mortality.&#xD;
&#xD;
      There is significant promise in the use of preoperative ketorolac to decrease the&#xD;
      inflammatory response after surgical resection of tumors, thereby potentially reducing the&#xD;
      risk of distant metastatic tumor spread and improving survival.&#xD;
&#xD;
      Patients will be screened and recruited during the preoperative period by the responsible&#xD;
      medical and surgical team. Blood will be drawn preoperatively and then at the end of the&#xD;
      surgical procedure. Participants will be randomized to either preoperative ketorolac group or&#xD;
      a concurrent control group who will not receive preincisional ketorolac. The concurrent&#xD;
      control group is to obtain untreated biologic samples for biologic correlative studies and&#xD;
      secondary endpoints. These patients will not be compared to the investigational cohort in&#xD;
      regards to the primary endpoint of safety. Patients will be randomized on the day of surgery&#xD;
      to either the experimental or control arms and participants will be followed or 28 days.&#xD;
      Medical records will be reviewed at 1 and 2 years post-surgery for survival assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Early Phase 1</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Blood Transfusion Among Ketorolac Group</measure>
    <time_frame>Prior to Hospital Discharge (generally up to 7 days post surgery)</time_frame>
    <description>Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as greater than two units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Clinically Significant Hematoma Development Among Ketorolac Group</measure>
    <time_frame>Prior to Hospital Discharge (generally up to 7 days post surgery)</time_frame>
    <description>Significant hematoma development will be assessed among participants receiving ketorolac.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Return to the Operating Room for Bleeding Among Ketorolac Group</measure>
    <time_frame>Prior to Hospital Discharge (generally up to 7 days post surgery)</time_frame>
    <description>The need for returning to the operating room for bleeding, as determined by the treating surgeon, will be assessed among participants receiving ketorolac.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Postoperative Renal Failure Among Ketorolac Group</measure>
    <time_frame>Prior to Hospital Discharge (generally up to 7 days post surgery)</time_frame>
    <description>Postoperative renal failure among participants receiving ketorolac will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Postoperative Morbidity Rate Among Ketorolac Group</measure>
    <time_frame>Prior to Hospital Discharge (generally up to 7 days post surgery)</time_frame>
    <description>Postoperative morbidity among participants receiving ketorolac will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-1 alpha (IL-1alpha) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-1alpha levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-1beta (IL-1β) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-1beta levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-2 (IL-2) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-2 levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-6 (IL-6) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-6 levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-8 (IL-8) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-8 levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-10 (IL-10) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-10 levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interleukin-12p70 (IL-12p70) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>IL-12p70 levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tumor Necrosis Factor-alpha (TNF-alpha) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>TNF-alpha levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interferon (INF)-gamma Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>INF-gamma levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>GM-CSF levels will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Monocyte Chemotactic and Activating Factor (MCAF) Levels</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>MCAF levels will be compared between study arms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Transcriptome Analysis</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>Transcriptome analysis will be performed to evaluate the effects of ketorolac on immune response pathways.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Flow Cytometry</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>Flow Cytometry will be performed to evaluate the effects of ketorolac on immune response pathways.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in T-Cell Receptor (TCR) Sequencing</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>T-Cell receptor (TCR) sequencing will be performed to evaluate the effects of ketorolac on immune response pathways.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Single Cell RNA Sequencing</measure>
    <time_frame>Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28</time_frame>
    <description>Single cell RNA sequencing will be performed to evaluate the effects of ketorolac on immune response pathways.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Preoperative Ketorolac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive ketorolac prior to surgery for stage I/II NSCLC and stage III RCC. Participants will receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the control group receiving the standard of care during surgery for stage I/II NSCLC and stage III RCC. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preoperative Ketorolac</intervention_name>
    <description>30 mg ketorolac will be administered intravenously 30 minutes prior to incision.</description>
    <arm_group_label>Preoperative Ketorolac</arm_group_label>
    <other_name>Acular</other_name>
    <other_name>Acuvail</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathology-proven or suspected stage 1 or 2 NSCLC and Stage 3 tumor stage 3, node stage&#xD;
             0 (T3N0) RCC, that require surgical resection as the treatment of choice&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with pure lung ground-glass opacity (GGO) lesions or mixed GGO with &lt;50%&#xD;
             solid component&#xD;
&#xD;
          -  Patients undergoing pneumonectomy&#xD;
&#xD;
          -  History of cancer in the 3 years prior to surgery (except for basal-cell carcinoma of&#xD;
             the skin or cervical neoplasia).&#xD;
&#xD;
          -  Contraindication for NSAIDs, including peptic ulcer disease, preoperative chronic&#xD;
             kidney disease with estimated glomerular filtration rate (eGFR) &lt;45, allergies or&#xD;
             intolerance to NSAIDs, coagulation disorder, or age &gt; 80 years&#xD;
&#xD;
          -  Having taken an NSAID within 5 days prior to surgery&#xD;
&#xD;
          -  Immunocompromised status&#xD;
&#xD;
          -  Refusal or inability to understand the protocol and consent form or to receive&#xD;
             follow-up in line with the recommendations&#xD;
&#xD;
          -  Preoperative hemoglobin &lt; 9.0&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viraj Master, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Onkar Khullar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Viraj Master, MD, PhD</last_name>
    <phone>404-778-4898</phone>
    <email>vmaster@emory.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Viraj Master</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data which will be available for sharing includes renal function data, complications of surgery, and immune correlates.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be available for sharing once results from this study are published.</ipd_time_frame>
    <ipd_access_criteria>Data will be available for validation analyses.</ipd_access_criteria>
  </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/NCT04495894
org study id: STUDY00000205
nct id: NCT04495894
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a pilot study of biomarker evaluation and safety of pre-incisional ketorolac for
      patients undergoing surgical resection for non-small cell lung cancer and renal cell
      carcinoma. There is significant promise in the use of preoperative ketorolac to decrease the
      inflammatory response after surgical resection of tumors, thereby potentially reducing the
      risk of distant metastatic tumor spread and improving survival. A total of 56 patients (28
      per disease site) will be enrolled into the experimental arm and will receive ketorolac prior
      to surgery. About 10 patients will be allocated randomly into a control group, for each
      disease site, for a total of 76 patients enrolled. The research will advance scientific
      knowledge by studying the safety of a preoperative dose of ketorolac prior to major surgical
      resection, which needs to be assessed prior to proceeding with a larger phase II study
      designed to evaluate traditional efficacy endpoints such as recurrence and overall survival.
Surgical resection is a cornerstone of standard-of-care treatment for early-stage non-small
      cell lung carcinoma (NSCLC) and renal cell carcinoma (RCC). Yet despite optimal treatment,
      many of these patients will develop cancer recurrence within the first few years. For
      example, the 5-year survival rate for patients with stage I/II NSCLC is only around 55%. As a
      result, more effective treatments that decrease cancer recurrence and increase survival are
      still needed.

      Surgery induces inflammation, immunosuppression and angiogenesis. Although these processes
      are important for wound healing in response to tissue injury caused by surgery, they also
      support the survival, growth and dissemination of any remaining cancer cells and can lead to
      systemic recurrence soon after surgery. Surgical trauma increases the production of
      prostaglandins and thromboxanes, which have tumor-promoting and immunosuppressive activities,
      and reduces the activity of natural killer cells, which impairs the ability of the immune
      system to keep cancer cells in check. However, if given just before tissue injury,
      non-steroidal anti-inflammatory drugs (NSAIDs) may be able to block the production of
      prostaglandins/thromboxanes and boost the activity of natural killer cells, and thereby
      decrease the risk of cancer recurrence. NSAIDs such as ketorolac are already routinely given
      to cancer patients postoperatively for pain management and are sometimes given
      intraoperatively (immediately before or during surgery) to prevent postoperative pain. A
      retrospective clinical analysis found that intraoperative intravenous ketorolac or diclofenac
      (another NSAID), when added to standard of care for patients with stage I/II NSCLC, was
      associated with decreased risks of distant recurrence and mortality.

      There is significant promise in the use of preoperative ketorolac to decrease the
      inflammatory response after surgical resection of tumors, thereby potentially reducing the
      risk of distant metastatic tumor spread and improving survival.

      Patients will be screened and recruited during the preoperative period by the responsible
      medical and surgical team. Blood will be drawn preoperatively and then at the end of the
      surgical procedure. Participants will be randomized to either preoperative ketorolac group or
      a concurrent control group who will not receive preincisional ketorolac. The concurrent
      control group is to obtain untreated biologic samples for biologic correlative studies and
      secondary endpoints. These patients will not be compared to the investigational cohort in
      regards to the primary endpoint of safety. Patients will be randomized on the day of surgery
      to either the experimental or control arms and participants will be followed or 28 days.
      Medical records will be reviewed at 1 and 2 years post-surgery for survival assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Incidence of Blood Transfusion Among Ketorolac Group
time frame: Prior to Hospital Discharge (generally up to 7 days post surgery)
description: Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as greater than two units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon.
measure: Incidence of Clinically Significant Hematoma Development Among Ketorolac Group
time frame: Prior to Hospital Discharge (generally up to 7 days post surgery)
description: Significant hematoma development will be assessed among participants receiving ketorolac.
measure: Incidence of Return to the Operating Room for Bleeding Among Ketorolac Group
time frame: Prior to Hospital Discharge (generally up to 7 days post surgery)
description: The need for returning to the operating room for bleeding, as determined by the treating surgeon, will be assessed among participants receiving ketorolac.
measure: Incidence of Postoperative Renal Failure Among Ketorolac Group
time frame: Prior to Hospital Discharge (generally up to 7 days post surgery)
description: Postoperative renal failure among participants receiving ketorolac will be assessed.
measure: Incidence of Postoperative Morbidity Rate Among Ketorolac Group
time frame: Prior to Hospital Discharge (generally up to 7 days post surgery)
description: Postoperative morbidity among participants receiving ketorolac will be assessed.
measure: Change in Interleukin-1 alpha (IL-1alpha) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-1alpha levels will be compared between study arms.
measure: Change in Interleukin-1beta (IL-1β) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-1beta levels will be compared between study arms.
measure: Change in Interleukin-2 (IL-2) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-2 levels will be compared between study arms.
measure: Change in Interleukin-6 (IL-6) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-6 levels will be compared between study arms.
measure: Change in Interleukin-8 (IL-8) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-8 levels will be compared between study arms.
measure: Change in Interleukin-10 (IL-10) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-10 levels will be compared between study arms.
measure: Change in Interleukin-12p70 (IL-12p70) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: IL-12p70 levels will be compared between study arms.
measure: Change in Tumor Necrosis Factor-alpha (TNF-alpha) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: TNF-alpha levels will be compared between study arms.
measure: Change in Interferon (INF)-gamma Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: INF-gamma levels will be compared between study arms.
measure: Change in Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: GM-CSF levels will be compared between study arms.
measure: Change in Monocyte Chemotactic and Activating Factor (MCAF) Levels
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: MCAF levels will be compared between study arms.
measure: Change in Transcriptome Analysis
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: Transcriptome analysis will be performed to evaluate the effects of ketorolac on immune response pathways.
measure: Change in Flow Cytometry
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: Flow Cytometry will be performed to evaluate the effects of ketorolac on immune response pathways.
measure: Change in T-Cell Receptor (TCR) Sequencing
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: T-Cell receptor (TCR) sequencing will be performed to evaluate the effects of ketorolac on immune response pathways.
measure: Change in Single Cell RNA Sequencing
time frame: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
description: Single cell RNA sequencing will be performed to evaluate the effects of ketorolac on immune response pathways.
arm group label: Preoperative Ketorolac
arm group type: Experimental
description: Participants randomized to receive ketorolac prior to surgery for stage I/II NSCLC and stage III RCC. Participants will receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered.
arm group label: Control Group
arm group type: No Intervention
description: Participants randomized to the control group receiving the standard of care during surgery for stage I/II NSCLC and stage III RCC. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
intervention type: Drug
intervention name: Preoperative Ketorolac
description: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
arm group label: Preoperative Ketorolac
other name: Acular
other name: Acuvail
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Viraj Master, MD, PhD
role: Principal Investigator
affiliation: Emory University
last name: Onkar Khullar, MD
role: Principal Investigator
affiliation: Emory University
last name: Viraj Master, MD, PhD
phone: 404-778-4898
email: vmaster@emory.edu
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Viraj Master
investigator title: Professor
mesh term: Carcinoma
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Carcinoma, Renal Cell
mesh term: Ketorolac
sharing ipd: Yes
ipd description: Individual participant data which will be available for sharing includes renal function data, complications of surgery, and immune correlates.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be available for sharing once results from this study are published.
ipd access criteria: Data will be available for validation analyses.