2024-515333-14-00撤回3 期
Targeting inflammation to reduce 90-day and 1-year postoperative severe morbidity in patients with unfavorable inflammatory profile undergoing oncologic surgery (POST-CARE trial)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
To test the role of the experimental intervention, consisting of the combination of preoperative ketorolac and post-operative low-dose aspirin plus hypoglycemic diet in reducing 90-day postoperative morbidity.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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
- •Ability of subject to understand and the willingness to sign a written informed consent document
- •Previous/ongoing aspirin therapy is not an exclusion criteria
- •Histologically documented cancer
- •Surgery performed for curative intent
- •High RBT index (≥18)
- •Patients scheduled for major surgical procedures (including thoracic, head and neck, abdominal (peritoneal/retroperitoneal), urogenital, and breast/reconstructive surgeries
- •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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •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
- •Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications
排除标准
- •Patients undergoing palliative surgery
- •Allogeneic tissue/solid organ transplant
- •Autologous/allogeneic stem cell transplantation
- •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
- •Known hypersensitivity to active substances (ketorolac and aspirin) or any of their excipients including previous clinically significant hypersensitivity reaction to treatments.
- •Medical contraindication to non-steroidal anti-inflammatory drugs / aspirin administration
- •Known history of human immunodeficiency virus (HIV) infection and/or HIV-related Kaposi Sarcoma
- •Known history of or positivity for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •History of (non-infectious) pneumonitis that required steroids or current pneumonitis; history of active tuberculosis (Bacillus tuberculosis)
- •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
- •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
- •Patients undergoing neuro-surgical procedures
- •Vaccination with live vaccine(s) within 30 days before the first dose of study treatment
- •Patients with specific or nutritional dietary requirement (malnutrition or at high risk for malnutrition, sarcopenic or high risk to be sarcopenic)
- •Low body mass index (BMI<18.5kg/m2)
- •Have type 1 diabetes mellitus or type 2 diabetes mellitus treated with insulin or insulin secretagogues
- •Any post-surgical nutritional requirements (e.g., patients deserving to have parenteral nutrition after discharge will be excluded from the trial)
- •Any patient with a known predisposing history of a coagulation or platelet defect
- •Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren’s, sarcoidosis etc.) detected at the time of screening.
- •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
结局指标
主要结局
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
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
次要结局
未报告次要终点
研究者
Clinical Trial Center
Scientific
Fondazione IRCCS Istituto Nazionale Dei Tumori
研究点 (1)
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