Periopertive administration of flurbiprofen axetil for prevention of postoperative recurrence in patients with non-small cell lung cancer

JRCT ID: jRCTs031190167

Registered date:23/12/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 05/02/2020
• Target sample size: 420
• Study type: Interventional

Intervention(s)

arm A: Surgery alone

arm B: Intravenous drip infusion of 50mg of flurbiprofen axetil given perioperatively

Outcome(s)

• Primary Outcome: Relapse-free survival (RFS)
• Secondary Outcome: Overall survival (OS), 1-year RFS rate, 2-year RFS rate, and the incidence of postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Watanabe Katsuya