Status:
TERMINATED
Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma
Lead Sponsor:
Emory University
Conditions:
Non-small Cell Lung Cancer
Renal Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 signif...
Detailed Description
Surgical resection is a cornerstone of standard-of-care treatment for early-stage non-small cell lung carcinoma (NSCLC) and renal cell carcinoma (RCC). Yet despite optimal treatment, many of these pat...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04495894
Start Date
August 24 2020
End Date
February 1 2024
Last Update
March 4 2025
Active Locations (4)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory Clinic
Atlanta, Georgia, United States, 30322
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Winship Cancer Institute
Atlanta, Georgia, United States, 30322