UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018480 |
|---|---|
| Receipt number | R000021362 |
| Scientific Title | Human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial |
| Date of disclosure of the study information | 2015/07/31 |
| Last modified on | 2020/08/01 10:17:30 |
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Basic information
Public title
Human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Acronym
Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP study)
Scientific Title
Human atrial natriuretic peptide during perioperative period for completely resected non-small cell lung cancer: a multicentre, open-label, randomised controlled trial
Scientific Title:Acronym
Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP study)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate whether human atrial natriuretic peptide (hANP) can reduce the incidence of postoperative cancer recurrence in patients with completely resected non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Two-year relapse free survival after lung cancer surgery
Key secondary outcomes
1. five-year relapse free survival after lung cancer surgery
2. Over all survival (5 years after surgery)
3. The ratio of the patients who completed the treatment
4. The incidence of postoperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Lung cancer surgery with hANP treatment [Patients in the hANP group receive human ANP (0.025 microgram/kg/min for 3 days), which is started more than two hours before surgery]
Interventions/Control_2
B: Surgery alone
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
Preoperative criteria
1. Non-small cell lung cancer is suspected.
2. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is more than 0.25.
3. It's possible to perfom the complete resection including mediastinal lymph node dissection.
4. Patient without simultaneous or metachronous (within the past 5 years) double cancers.
5. Aged more than 20 years
6. Performance status of 0-2.
7. Sufficient organ functions.
8. All patients gave written informed consent
Key exclusion criteria
1. Thin-section CT fulfills the proportion of maximum diameter of the tumor itself to consolidation is less than 0.25.
2. Patient with active the other concurrent malignant diseases.
3. Women during pregnancy or breast-feeding.
4. Psychosis.
5. Systemic steroids or immunosuppressive agents medication.
6. Uncontrollable infectious disease, autoimmune disease, or the other severe comorbidities.
7. History of right ventricular infarction.
8. Severe hypotension
9. Other conditions judged ineligible by physician
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenji Kangawa/Meinoshin Okumura |
| Middle name | |
| Last name | Kenji Kangawa/Meinoshin Okumura |
Organization
National Cerebral and Cardiovascular Center Research Institute/Osaka University Graduate School of Medicine
Division name
Biochemistry/General Thoracic Surgery
Zip code
565-8565
Address
5-7-1, Fujishiro-dai, Suita-city, Osaka 565-8565, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka 565-0871, Japan
TEL
06-6833-5012
kangawa@ri.ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nojiri |
Organization
National Cerebral and Cardiovascular Center Research Institute/Osaka University Hospital
Division name
Biochemistry/General Thoracic Surgery
Zip code
565-8565
Address
5-7-1, Fujishiro-dai, Suita-city, Osaka, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka, Japan
TEL
06-6833-5012
Homepage URL
nojiri@ri.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
Osaka, Japan/2-2 (L5), Yamadaoka, Suita-City, Osaka, Japan
Tel
06-6833-5012
nojiri@ri.ncvc.go.jp
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
大阪大学医学部附属病院（大阪府）
大阪府立成人病センター（大阪府）
国立病院機構刀根山病院（大阪府）
大阪府立呼吸器・アレルギー医療センター（大阪府）
北海道大学病院（北海道）
山形大学医学部附属病院（山形県）
山形県立中央病院（山形県）
東京大学医学部附属病院（東京都）
神戸大学医学部附属病院（兵庫県）
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 31 | 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
332
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021362
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