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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031190167

Enrollment

420

Registered

2019-12-23

Start date

2020-02-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer non-small cell lung cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 = 92%). 8. Written informed consent is provided by the patient.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Relapse-free survival (RFS)	—

Secondary

Measure	Time frame
Overall survival (OS), 1-year RFS rate, 2-year RFS rate, and the incidence of postoperative complications	—

Contacts

Public ContactKatsuya Watanabe

National hospital organization Yokohama medical center

katsuyawata921@gmail.com+81-45-851-2621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026