NCT04495894|TerminatedPhase 2ResultsDMCFDA Drug
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This study was terminated after interim analyses showed no benefits.
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
Sponsor study identifier
interventional
68
1 country
4
Study Start
August 24, 2020
Actual (reported)Primary Completion
February 1, 2024
Actual (reported)Study Completion
February 1, 2024
Actual (reported)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. This 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2020
Actual (reported)August 3, 2020
Actual (reported)August 24, 2020
Actual (reported)February 1, 2024
Actual (reported)February 1, 2024
Actual (reported)March 4, 2025
Actual (reported)Number of Participants Receiving a Blood Transfusion
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 needing two or more units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon.
Prior to Hospital Discharge (up to 13 days post surgery)
Number of Participants Experiencing Clinically Significant Hematoma Development
Post-surgical significant hematoma development is assessed as the number of participants experiencing a hematoma prior to hospital discharge.
Prior to Hospital Discharge (up to 13 days post surgery)
Number of Participants Returning to the Operating Room for Bleeding
Post-operative bleeding is assessed at the number of participants needing to return to the operating room for bleeding, as determined by the treating surgeon.
Prior to Hospital Discharge (up to 13 days post surgery)
Number of Participants Experiencing Postoperative Renal Failure
Postoperative renal failure is assessed as the number of participants experiencing renal failure prior to hospital discharge.
Prior to Hospital Discharge (up to 13 days post surgery)
Transcriptome Analysis
Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
Flow Cytometry
Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
T-Cell Receptor (TCR) Sequencing
Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Viraj Master, MD, PhD
Emory University
Onkar Khullar, MD
Emory University
68 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2020
First Posted
August 3, 2020
Study Start
August 24, 2020
Actual (reported)Number of Participants Experiencing Postoperative Morbidity
Postoperative morbidity is assessed as the count of participants experiencing at least one adverse event or serious adverse event from surgery to hospital discharge.
Prior to Hospital Discharge (up to 13 days post surgery)
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2024
Actual (reported)Study Completion
February 1, 2024
Actual (reported)Last Updated
March 4, 2025
Results First Posted
March 4, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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