UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037580 |
|---|---|
| Receipt number | R000042815 |
| Scientific Title | Single-arm phase II trial to evaluate safety of laparoscopic total gastrectomy with spleen-preserving splenic hilar dissection for proximal gastric cancer invading the greater curvature |
| Date of disclosure of the study information | 2019/08/02 |
| Last modified on | 2019/08/02 09:38:31 |
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Basic information
Public title
Single-arm phase II trial to evaluate safety of laparoscopic total gastrectomy with spleen-preserving splenic hilar dissection for proximal gastric cancer invading the greater curvature(JCOG1809, LTG-SPRING-PII)
Acronym
Single-arm phase II trial to evaluate safety of laparoscopic total gastrectomy with spleen-preserving splenic hilar dissection for proximal gastric cancer invading the greater curvature(JCOG1809, LTG-SPRING-PII)
Scientific Title
Single-arm phase II trial to evaluate safety of laparoscopic total gastrectomy with spleen-preserving splenic hilar dissection for proximal gastric cancer invading the greater curvature
Scientific Title:Acronym
Single-arm phase II trial to evaluate safety of laparoscopic total gastrectomy with spleen-preserving splenic hilar dissection for proximal gastric cancer invading the greater curvature
Region
| Japan |
Condition
Condition
cT2 (MP) - T4a (SE) gastric cancer invading the greater curvature
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of laparoscopic/robotic spleen-preserving splenic hilar dissection with prophylactic intention for proximal gastric cancer invading the greater curvature
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of pancreatic fistula and/or abdominal abscess
Key secondary outcomes
Blood loss, operation time, surgery-related death, overall complication, number of removed splenic hilar nodes, number of metastatic splenic hilar nodes, conversion to open surgery, conversion to splenectomy, relapse-free survival, overall survival
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
| Maneuver |
Interventions/Control_1
Laparoscopic/robotic spleen-preserving splenic hilar dissection
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically proven gastric adenocarcinoma by endoscopic biopsy.
2)Clinical T2(MP)-T4a(SE) located in the U area of the stomach and invading the greater curvature (Gre).
3)No swollen lymph nodes detected by CT scan at the splenic hilum larger than 10 mm in diameter in major axis or 8 mm in diameter in minor axis. No direct invasion to the spleen, pancreas, or splenogastric ligament.
4)H0P0M0 and no bulky metastatic lymph nodes (bulky N2) by contrast-enhanced chest - abdominal computed tomography.
5) Neither Borrmann type 4 nor large (>8cm) type 3.
6)No esophageal invasion
7)Not a stump cancer of stomach
8) Expected R0 surgery
9) Body mass index (BMI) is less than 30
10)Aged between 20 and 85 years old
11)Eastern Cooperative Oncology Group performance status of 0 or 1.
12)No history of upper abdominal surgery or intestinal resection
13)No prior chemotherapy or radiotherapy for any malignancies except adjuvant chemotherapy after curative resection
14)Adequate organ functions defined as;
i) WBC of 3,000/mm3 or more
ii) Platelet count100,000/mm3 or more
iii) T.Bil of 2.0 mg/dL or less
iv) AST of 100 IU/L or less
v) ALT of 100 IU/L or less
vi) Creatinine of 1.5 mg/dL or less
15) Written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies.
2) Infectious disease requiring systemic treatment.
3) Body temperature of 38 degrees Celsius or higher.
4) During pregnancy, within 28 days postpartum, or during lactation.
5) Severe mental disease.
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy
9) HIV antibody positive
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | KINOSHITA |
Organization
National Cancer Center east Hospital
Division name
Gastric Surgery Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
JCOG_sir@ml.jcog.jp
Public contact
Name of contact person
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | KINOSHITA |
Organization
JCOG1809 Coordinating Office
Division name
Gastric Surgery Division, National Cancer Center East Hospital
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111(5573)
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.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
函館厚生院函館五稜郭病院（北海道）
恵佑会札幌病院（北海道）
岩手医科大学（岩手県）
国立病院機構仙台医療センター（宮城県）
宮城県立がんセンター（宮城県）
山形県立中央病院（山形県）
総合南東北病院（福島県）
栃木県立がんセンター（栃木県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
がん・感染症センター都立駒込病院（東京都）
東京医科歯科大学（東京都）
がん研究会有明病院（東京都）
虎の門病院（東京都）
都立墨東病院（東京都）
東海大学医学部付属八王子病院（東京都）
神奈川県立がんセンター（神奈川県）
北里大学医学部（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
新潟県厚生連長岡中央綜合病院（新潟県）
富山県立中央病院（富山県）
石川県立中央病院（石川県）
岐阜大学医学部（岐阜県）
岐阜市民病院（岐阜県）
大垣市民病院（岐阜県）
静岡県立総合病院（静岡県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター（愛知県）
名古屋大学医学部（愛知県）
国立病院機構京都医療センター（京都府）
京都第2赤十字病院（京都府）
大阪大学医学部（大阪府）
近畿大学病院（大阪府）
大阪国際がんセンター（大阪府）
国立病院機構大阪医療センター（大阪府）
大阪急性期・総合医療センター（大阪府）
大阪医科大学（大阪府）
市立豊中病院（大阪府）
堺市立総合医療センター（大阪府）
関西医科大学附属病院（大阪府）
大阪労災病院（大阪府）
神戸大学医学部（兵庫県）
関西労災病院（兵庫県）
兵庫医科大学（兵庫県）
兵庫県立がんセンター（兵庫県）
市立伊丹病院（兵庫県）
和歌山県立医科大学（和歌山県）
島根大学医学部（島根県）
岡山大学病院（岡山県）
広島大学病院（広島県）
広島市立広島市民病院（広島県）
国立病院機構福山医療センター（広島県）
広島市立安佐市民病院（広島県）
福山市民病院（広島県）
徳島赤十字病院（徳島県）
香川県立中央病院（香川県）
国立病院機構四国がんセンター（愛媛県）
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042815
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| Registered date | File name |
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