TerminatedPhase 2NCT04495894
Official study title

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

Study 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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedPreoperative Ketorolac

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 4, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Emory University

Study sponsor

01
Study overview

What this study is about

Purpose
Other
Study type
Interventional
Phase
Phase 2
Sponsor
Emory University
Interventions being studied
Drug: Preoperative Ketorolac
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Emory University Hospital MidtownAtlanta, Georgia
  • Emory ClinicAtlanta, Georgia
  • Emory University HospitalAtlanta, Georgia
  • Winship Cancer InstituteAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 4, 2025. Always confirm current availability with the study team.

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