KETOROLAC TROMETAMOL for Oncologic surgery | Postoperative morbidity

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Adequate organ function: absolute neutrophil count ≥ 1,500/mm^3 platelet count ≥ 100,000/mm^3 hemoglobin ≥ 9 g/dl AST and ALT ≤ 1.5* times upper limit of normal (ULN) bilirubin ≤ 1.5* times ULN creatinine clearance ≥ 45 ml/min or serum creatinine ≤1.5 x ULN NOTE: * ≤ 3 times ULN if liver metastases are present\n- Ability of subject to understand and the willingness to sign a written informed consent document\n- Previous/ongoing aspirin therapy is not an exclusion criteria\n- Histologically documented cancer\n- Surgery performed for curative intent\n- High RBT index (≥18)\n- Patients scheduled for major surgical procedures (including thoracic, head and neck, abdominal (peritoneal/retroperitoneal), urogenital, and breast/reconstructive surgeries\n- Major surgery is defined according to the extent and complexity of the procedure, its pathophysiological consequences and consecutive clinical outcomes, according to the criteria proposed by Marin et al. in 2020\n- Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n- Female participants must not be pregnant, not breastfeeding. Women of childbearing age must agree to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment\n- Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications"}

Exclusion criteria

• {"criterion_text":"- Patients undergoing palliative surgery\n- Allogeneic tissue/solid organ transplant\n- Autologous/allogeneic stem cell transplantation\n- Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n- Known hypersensitivity to active substances (ketorolac and aspirin) or any of their excipients including previous clinically significant hypersensitivity reaction to treatments.\n- Medical contraindication to non-steroidal anti-inflammatory drugs / aspirin administration\n- Known history of human immunodeficiency virus (HIV) infection and/or HIV-related Kaposi Sarcoma\n- Known history of or positivity for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n- History of (non-infectious) pneumonitis that required steroids or current pneumonitis; history of active tuberculosis (Bacillus tuberculosis)\n- Clinically significant cardiovascular disease within 12 months of the first dose of study treatment including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability\n- Prior therapy with a monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before administration of study treatment\n- Vaccination with live vaccine(s) within 30 days before the first dose of study treatment\n- Patients undergoing neuro-surgical procedures\n- Patients with specific or nutritional dietary requirement (malnutrition or at high risk for malnutrition, sarcopenic or high risk to be sarcopenic)\n- Low body mass index (BMI<18.5kg/m2)\n- Have type 1 diabetes mellitus or type 2 diabetes mellitus treated with insulin or insulin secretagogues\n- Any post-surgical nutritional requirements (e.g., patients deserving to have parenteral nutrition after discharge will be excluded from the trial)\n- Any patient with a known predisposing history of a coagulation or platelet defect\n- Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren’s, sarcoidosis etc.) detected at the time of screening.\n- Diagnosis of immunodeficiency or chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment"}

Primary endpoints

• {"endpoint_text":"- to test the efficacy of preoperative ketorolac followed by postoperative, dietary and pharmacologic glycemic/inflammatory control (through a combination of Mediterranean diet and low-dose aspirin) in reducing 90-day surgery-related morbidity (grade 3 or more according to the Clavain Dindo Classification) in high-risk patients (those with an RBT≥18) undergoing major surgical procedures","definition_or_measurement_approach":"90-day surgery-related morbidity defined as grade 3 or more according to the Clavien-Dindo Classification in patients with RBT ≥ 18 undergoing major surgery (i.e., count of events of Clavien-Dindo grade ≥3 within 90 days postoperative)."}

Italy

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

07-02-2025

Processing Time Days

46

Number Of Sites

1

Number Of Participants

444

Primary sponsor

Full Name

Fondazione IRCCS Istituto Nazionale Dei Tumori

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy