Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma

NCT04495894 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00000205
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer; Renal Cell Carcinoma

Keywords

Surgery

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

Other Outcomes (15)

• 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

Study Arms (4)

Preoperative Ketorolac For Participants with Non-small Cell Lung Carcinoma (NSCLC)

EXPERIMENTAL

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.

Drug: Preoperative Ketorolac

Control Group For Participants with Non-small Cell Lung Carcinoma (NSCLC)

NO INTERVENTION

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.

Preoperative Ketorolac For Participants with renal cell carcinoma (RCC)

EXPERIMENTAL

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.

Drug: Preoperative Ketorolac

Control Group For Participants with renal cell carcinoma (RCC)

NO INTERVENTION

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.

Interventions

Preoperative Ketorolac DRUG

30 mg ketorolac will be administered intravenously 30 minutes prior to incision.

Also known as: Acular, Acuvail

Preoperative Ketorolac For Participants with Non-small Cell Lung Carcinoma (NSCLC); Preoperative Ketorolac For Participants with renal cell carcinoma (RCC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology-proven or suspected stage 1 or 2 NSCLC and Stage 3 tumor stage 3, node stage 0 (T3N0) RCC, that require surgical resection as the treatment of choice
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Ability to understand and the willingness to sign an informed written consent

You may not qualify if:

• Individuals with pure lung ground-glass opacity (GGO) lesions or mixed GGO with \<50% solid component
• Patients undergoing pneumonectomy
• History of cancer in the 3 years prior to surgery (except for basal-cell carcinoma of the skin or cervical neoplasia).
• Contraindication for NSAIDs, including peptic ulcer disease, preoperative chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45, allergies or intolerance to NSAIDs, coagulation disorder, or age \> 80 years
• Having taken an NSAID within 5 days prior to surgery
• Immunocompromised status
• Refusal or inability to understand the protocol and consent form or to receive follow-up in line with the recommendations
• Preoperative hemoglobin \< 9.0

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Interventions

Ketorolac Tromethamine; Ketorolac

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Viraj Master, MD, PhD
• Organization: Emory University

vmaster@emory.edu

404-778-4898

Study Officials

• Viraj Master, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Onkar Khullar, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: August 24, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)