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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Ketorolac

Criteria

Inclusion 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

Exclusion 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