|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000029411 |
|
Date of registration:
|
15/10/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
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
|
|
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 - PIII-PEOPLE study |
|
Date of first enrolment:
|
2017/10/15 |
|
Target sample size:
|
230 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033606 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase III
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Ichiro Yoshino |
|
Address:
|
1-8-1, Inohana, Chuo-ku, Chiba
Japan |
|
Telephone:
|
043-222-7171 |
|
Email:
|
iyoshino@faculty.chiba-u.jp |
|
Affiliation:
|
Chiba University Graduate School of Medicine Department of General Thoracic Surgery |
|
|
Name:
|
Yuichi Sakairi |
|
Address:
|
1-8-1, Inohana, Chuo-ku, Chiba
Japan |
|
Telephone:
|
043-222-7171 |
|
Email:
|
y_sakairi1@chiba-u.jp |
|
Affiliation:
|
Chiba University Graduate School of Medicine Department of General Thoracic Surgery |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
non-small-cell lung cancer combined with idiopathic pulmonary fibrosis
|
|
Intervention(s)
|
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.
Acute exacerbation prophylaxis is performed (not specified. but decided in each facility)
|
|
Primary Outcome(s)
|
|
IPF exacerbation rate within 30 days after surgery
|
|
Secondary Outcome(s)
|
|
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.
|
|
Source(s) of Monetary Support
|
|
North East Japan Study Group
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|