Periopertive administration of flurbiprofen axetil for prevention of postoperative recurrence in patients with non-small cell lung cancer: A phase II multicentered, randomized, controlled trial - FLAX study

Watanabe Katsuya0 个研究点目标入组 420 人开始时间: 2019年12月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. c-stage IA to IIIA NSCLC is suspected.
•2. Radiologically diagnosed invasive lung tumor with a solid component >= 1.0cm is visualized by thin-section computed tomography (CT).
•3. Complete resection including mediastinal lymph node dissection or sampling is planned.
•4. Patients must not have synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
•5. Patients must be aged 20 years or older.
•6. Eastern Cooperative Oncology Group performance status must be 0-2.
•7. Organ function must be sufficient (leukocyte count >= 1500 per microliter, hemoglobin >= 8.0 g/dl, platelet count >= 100,000 per microliter, aspartate aminotransferase <=80 IU/l, alanine aminotransferase <= 80 IU/l, serum creatinine <=1.5 mg/dl, peripheral arterial oxygen saturation on room air >= 92%).
•8. Written informed consent is provided by the patient.

•1. Active concurrent malignant disease, except carcinoma in situ or intra mucosal disease cured by local therapy
•2. Current disease or condition that would make the subject inappropriate for study participation (uncontrolled or symptomatic angina or myocardial infarction within the past 3months, congestive heart failure, clinically significant arrhythmias, severe hypertension, unstable diabetes mellitus, peptic ulcer bleeding, uncontrollable infectious disease)
•3. Pregnant, lactating, or potentially pregnant
•4. Regularly administrating of NSAIDs
•5. History of NSAIDs-related allergy
•6. Systemic steroids or immunosuppressive agent medication
•7. Administration of quinolone antibiotics such as enoxacin, lomefloxacin, norfloxacin, and prulifloxacin

发起方

Watanabe Katsuya