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
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
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
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
