UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase III study of perioperative pirfenidone therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) for confirming the effect for prevention of postoperative acute exacerbation
Title of the study (Brief title)	PIII-PEOPLE study
Region	Japan

Condition
Condition	non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The effect of suppressing acute exacerbation by perioperative pirfenidone therapy for IPF-associated lung cancer patients subject to surgery is examined by comparison with the control group.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	IPF exacerbation rate within 30 days after surgery
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	Acute exacerbation prophylaxis is performed (not specified. but decided in each facility)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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.
Target sample size	230

Research contact person
Name of lead principal investigator	Ichiro Yoshino
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email	iyoshino@faculty.chiba-u.jp

Public contact
Name of contact person	Yuichi Sakairi
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	y_sakairi1@chiba-u.jp

Sponsor
Institute	North East Japan Study Group
Institute
Department

Funding Source
Organization	North East Japan Study Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 28 Day
Anticipated trial start date	2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 04 Day
Last modified on	2019 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033606