UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Title of the study (Brief title)	Perioperative pirfenidone for lung cancer with fibrosis evaluation (PEOPLE)
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	We will detect the effect and safety of perioperative pirfenidone therapy for preventing acute exacerbation of idiopathic pulmonary fibrosis (IPF) in patients with non-small-cell lung cancer combined with IPF.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Non-incidence of acute exacerbation of IPF within 30 days after the surgery
Key secondary outcomes	Safety : complications due to pirfenidone (e.g., digestive organ toxicity and photo-allergy) and other general complications after surgery

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of pirfenidone starting from 4-6 weeks before the surgery.
Interventions/Control_2
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) 20y.o. <= age <= 75y.o. 2)Cytological, histological, or roentgenological diagnosis of non-small-cell lung cancer 3) UIP pattern or possible UIP pattern of "high-resolution computed tomography criteria for UIP pattern" published by ATS/ERS/JRS/ALAT in 2011. 4) Tolerability for the general anesthesia. 5) Resectable cancer lesion by surgery less than single lobectomy 6) Predicted post-surgical FEV1.0 >=1000ml 7)Possibility of oral administration of the drugs 8)Performance Status (ECOG Scale):0 or 1 9)Written informed consent before registration
Key exclusion criteria	1)History of thoracotomy or video-assisted thoracoscopic surgery (We accept the patients who have the history of surgical biopsy for diagnosing IPF more than 6 months ago.) 2) Treatment history of IPF (e.g., pirfenidone, steroid, erythromycin, and immunosuppressors) before registration. When these drugs which can become the treatment of IPF were used even if for other diseases, we exclude this case. 3) History of radiation therapy (which include a lung in the treatment field) or chemotherapy. 4) Other known causes of interstitial pneumonia (e.g., environmental exposures, connective tissue disease, and drug toxicity). 5) Induced oxygen therapy 6) Local or systemic active infection which requires treatment. 7) Severe complications (e.g., bleeding from digestive organs, heart diseases, glaucoma, and diabetes). 8) History of severe hypersensitivity. 9) Mental diseases which prevent from registration of this trial. 10) Pregnant ladies, nursing ladies, the ladies with possibility of pregnancy, or the ladies who does not have intention to prevent pregnancy. 11) Obvious history of acute exacerbation of IPF. 12) Judged as inappropriate for this trial by the medical attendant by other reasons.
Target sample size	42

Research contact person
Name of lead principal investigator	Ichiro Yoshino
Organization	Graduate School of Medicine, Chiba University
Division name	Division of General Thoracic Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
TEL	043-222-7171
Email	iyoshino@faculty.chiba-u.jp

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Address	Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	None
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	2012 Year 04 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 31 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2015 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/27450274
Results
Other related information

Management information
Registered date	2012 Year 04 Month 16 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009124