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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029411
Receipt No. R000033606
Scientific Title 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
Date of disclosure of the study information 2017/10/15
Last modified on 2019/02/02

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Basic information
Public title 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
Acronym PIII-PEOPLE study
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Ichiro Yoshino
Organization Chiba University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email iyoshino@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Sakairi
Organization Chiba University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code
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)

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
2017 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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