UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008277 |
|---|---|
| Receipt number | R000009755 |
| Scientific Title | A Prospective Phase II Multicenter Study for Prophylaxis of Acute Exacerbations of Interstitial Lung Disease after Lung Cancer Resection |
| Date of disclosure of the study information | 2012/06/29 |
| Last modified on | 2022/07/04 12:53:12 |
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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
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
h-ito@kcch.jp
Sponsor or person
Institute
Yokohama Consortium of Thoracic Surgeons
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009755
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