臨床研究等提出・公開システム

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)

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

Watanabe Katsuya

National hospital organization Yokohama medical center

3-60-2, Harajuku, Totsuka Ward, Yokohama, Kanagawa, Japan

katsuyawata921@gmail.com

Watanabe Katsuya

National hospital organization Yokohama medical center

3-60-2, Harajuku, Totsuka Ward, Yokohama, Kanagawa, Japan

+81-45-851-2621

katsuyawata921@gmail.com

Not Recruiting

Dec. 23, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

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

Both

non-small cell lung cancer

arm A: Surgery alone

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

non-small cell lung cancer

Relapse-free survival (RFS)

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

+81-49-276-1662

Sept. 27, 2019

none