non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
Conditions
Interventions
Oral pirfenidone (600mg) is administrated for 14days after registration, and oral pirfenidone (1200mg) for more 14days before surgery. It'
s recommended continuing oral pirfenidone as long as possible even after surgery.
Acute exacerbation prophylaxis is performed (not specified. but decided in each facility)
Sponsors
North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Cases with ages over 20 (2) Cases with c-stage 0-IIIA non-small cell lung cancer diagnosed cytologically or histologically, or strongly suspected radiologically (3) Cases diagnosed as IPF on HRCT (possible UIP / definitive UIP under the 2011 International Guidelines) (4) Cases that are tolerable to general anesthesia (5) Cases with resectable lesions by lobectomy (6) Cases that satisfy the following criteria within 14 days before registration. 1) Neutrophils: 1,500 / mm3 or more 2) Hemoglobin: not less than 10.0 g / dL 3) Platelets: 10.0 x 10^4 / mm3 or more 4) AST: 3 times or less of upper limit of facility reference value 5) ALT: 3 times or less of upper limit of facility reference value 6) Total bilirubin: 1.5 times or less of upper limit of the facility reference value 7) SpO 2 90% or more 8) Serum creatinine: 1.5 times or less of upper limit of facility reference value (7) Cases with postoperative predicted FEV1 is more than 1000 mL (8) Cases with good oral intake (9) Cases in which performance status (ECOG Scale) is 0 or 1 (10) Cases in which written consent has been obtained from the patient himself / herself after adequate explanation was made before study registration
Exclusion criteria
Exclusion criteria: (1) Patients with past thoracotomy or thoracoscopic surgery (the cases with surgical biopsy for IPF diagnostic purposes or the cases after 6 months or more since biopsy were excluded) (2) Cases with prior therapies for IPF (pirfenidone, nintedanib, immunosuppressive drugs, etc.) (3) Cases in which corticosteroids, macrolide antibiotics or both are currently administered (4) Cases with a history of chemotherapy and/or radiotherapy in which the lung enters the irradiation field (5) Cases in which the cause of interstitial pneumonia is revealed, such as drug properties, environmental exposure, collagen disease, etc. (6) Cases receiving oxygen therapy (7) Cases with local or systemic active infections requiring treatment (8) Cases with severe complications such as poor control heart disease, glaucoma, diabetes, gastrointestinal bleeding, etc. (9) Cases with a history of severe hypersensitivity (10) Cases those are considered difficult to register due to mental illness (11) Pregnant women, lactating women, women who are currently pregnant, or women who are not willing to contraceptive (12) Cases with a history of obvious IPF acute exacerbation in the past (13) Other cases judged inappropriate by the attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPF exacerbation rate within 30 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) postoperative IPF exacerbation free period (within 90 days) 2) Comparison of incidence of complications due to pirfenidone, or general postoperative complications. 3) Overall and recurrence free survival rate for 2 years after surgery, exacerbation free survival rate of IPF, and sub-analysis for each other preventive treatment. 4) Comparison of acute exacerbation risk score, and assessment of adequacy of the risk score. 5) Evaluation of correct rate of radiological IPF diagnosis after central decision. 6) Sub-analysis for IPF and non-IPF after central decision, of the rate of acute exacerbation within 30 days after surgery, IPF exacerbation free period, and effects of pirfenidone. | — |
Countries
Japan
Contacts
Public ContactYuichi Sakairi
Chiba University Graduate School of Medicine Department of General Thoracic Surgery
Outcome results
None listed