UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Phase II Multicenter Study for Prophylaxis of Acute Exacerbations of Interstitial Lung Disease after Lung Cancer Resection
Acronym	Sivelestat sodium Hydrate with low dose methylprednisolone for prevention of postoperative Interstitial Pneumonia (SHIP)
Scientific Title	A Prospective Phase II Multicenter Study for Prophylaxis of Acute Exacerbations of Interstitial Lung Disease after Lung Cancer Resection
Scientific Title:Acronym	Sivelestat sodium Hydrate with low dose methylprednisolone for prevention of postoperative Interstitial Pneumonia (SHIP)
Region	Japan

Condition
Condition	Interstitial pneumonia Lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will analyze the feasibility and efficacy of perioperative sivelestat sodium hydrate with low dose methylprednisolone therapy on patients with resectable lung cancer comorbid with interstitial pneumonia for the prevention of acute exacerbation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of acute exacerbation of interstitial pneumonia within 30 days after lung cancer surgery
Key secondary outcomes	Pathological accuracy of interstitial pneumonia, Postoperative morbidity and mortality, Overall survival rate, Disease free survival rate, Incidence of secondary lung cancer.

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	Just before general anesthesia, intravenous infusion of methylprednisolone and continuous drip of sivelestat sodium hydrate are administered.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically confirmed or suspected lung cancer 2)cStage IA-IIIA, resectable 3)lobectomy or segmentectomy is planned 4)the case diagnosed as suspicious of interstitial pneumonia by one radiologist and pulmonologist. Honeycomb or fibrosis just under the pleura three or more segments in both lower lobe with high resolution computed tomography. 5)performance status of 0 to 1 6)No incidence of chest irradiation or chemotherapy. 7)Adequate hematologic, hepatic, renal, and cardiac function. WBC >=4,000/mm3 Absolute neutrophil count 2,000/mm3 Platelet count >=100,000/mm3 Hemoglobin >=10.0g/dL AST and ALT <80IU/L Total bilirubin <1.5mg/dL Creatinine 1.5 <1.3gm/dl PaO2>=70Torr(room air) Predicted postoperative FEV1>=0.8L. %DLco>=40% 8)Written informed consent
Key exclusion criteria	1)History of cancer treatment within 5 years (except carcinoma in situ). History of radiation therapy (which include a lung in the treatment field) or chemotherapy. 2)Severe comorbidities (uncontrolled ischemic heart disease or myocardial infarction within three months. Uncontrolled diabetes, hypertension and infection) 3)Pregnant ladies, nursing ladies, the ladies with possibility of pregnancy. 4)Patients who takes steroid therapy 5)Treatment history of interstitial pneumonia with pirfenidone.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Haruhiko Nakayama
Organization	Kanagawa Cancer Center
Division name	Thoracic Surgery
Zip code
Address	2-3-2 Nakao, Asahi-ku, Yokohama 241-0815, Japan
TEL	045-520-2222
Email	nakayama-h@kcch.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Ito
Organization	Kanagawa Cancer Center
Division name	Thoracic Surgery
Zip code
Address	2-3-2 Nakao, Asahi-ku, Yokohama 241-0815, Japan
TEL	045-520-2222
Homepage URL
Email	h-ito@kcch.jp

Sponsor
Institute	Yokohama Consortium of Thoracic Surgeons
Institute
Department

Funding Source
Organization	The Waksman foundation of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	横浜市立大学附属病院（神奈川県） 横浜市立大学市民総合医療センター（神奈川県） 神奈川県立がんセンター呼吸器外科（神奈川県） 横須賀共済病院（神奈川県） 横浜労災病院（神奈川県） 神奈川県立循環器呼吸器病センター（神奈川県） 横浜医療センター（神奈川県） 横須賀市立うわまち病院（神奈川県） 横浜南共済病院（神奈川県） 藤沢湘南台病院（神奈川県） 関東労災病院（神奈川県） 平塚共済病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 29 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2012 Year 06 Month 15 Day
Date of IRB	2012 Year 06 Month 20 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 06 Month 27 Day
Last modified on	2022 Year 07 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009755