UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007774
Receipt number R000009124
Scientific Title 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)
Date of disclosure of the study information 2012/04/16
Last modified on 2016/08/09 17:36:10

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Basic information

Public title

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)

Acronym

Perioperative pirfenidone for lung cancer with fibrosis evaluation (PEOPLE)

Scientific Title

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)

Scientific Title:Acronym

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

1st name
Middle name
Last name Ichiro Yoshino

Organization

Graduate School of Medicine, Chiba University

Division name

Division of General Thoracic Surgery

Zip code


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

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


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 or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27450274

Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 03 Month 31 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name