Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma
Megadott ok: This study was terminated after interim analyses showed no benefits.
Key facts
- Where
- Atlanta, Egyesült ÁllamokSee the 4 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- Emory ClinicAtlanta, Egyesült ÁllamokNo longer taking part
- Emory University HospitalAtlanta, Egyesült ÁllamokNo longer taking part
- Emory University Hospital MidtownAtlanta, Egyesült ÁllamokNo longer taking part
- Winship Cancer InstituteAtlanta, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Emory University
- Trial code
- NCT04495894
- Record updated
- 2025. március 4.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Having taken an NSAID within 5 days prior to surgery; 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; Preoperative hemoglobin < 9.0; Individuals with pure lung ground-glass opacity (GGO) lesions or mixed GGO with <50% solid component; Patients undergoing pneumonectomy; Immunocompromised status; Refusal or inability to understand the protocol and consent form or to receive follow-up in line with the recommendations.