UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039825 |
|---|---|
| Receipt number | R000045343 |
| Scientific Title | Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 Gastric Cancer patients |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2023/06/30 18:14:30 |
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Basic information
Public title
Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 Gastric Cancer patients
(JCOG1907, MONA LISA study)
Acronym
Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 Gastric Cancer patients
(JCOG1907, MONA LISA study)
Scientific Title
Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 Gastric Cancer patients
Scientific Title:Acronym
Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-4aN0-3 Gastric Cancer patients
Region
| Japan |
Condition
Condition
clinical stage T1-4aN0-3 Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for the safety of patients with clinical T1-4aN0-3 gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of postoperative intra-abdominal infectious complications including leakage, pancreatic fistula, and abdominal abscess with Clavien-Dindo grade II and more
Key secondary outcomes
Incidence of postoperative complications with Clavien-Dindo grade II and more, incidence of postoperative complications with Clavien-Dindo grade IIIA and more, incidence of postoperative intra-abdominal infectious complications with Clavien-Dindo grade IIIA and more, relapse-free survival, overall survival, proportion of robot-assisted gastrectomy completion, proportion of laparoscopic gastrectomy completion, proportion of conversion to open surgery, proportion of surgery-related death, short-term clinical outcomes after gastrectomy
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
| Maneuver |
Interventions/Control_1
A:Laparoscopic gastrectomy with nodal dissection
Interventions/Control_2
B:Robot-assisted gastrectomy with nodal dissection
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 proven gastric adenocarcinoma by endoscopic biopsy.
2) Clinical T1-T4a and N0-N3 diagnosed by contrast-enhanced abdominal computed tomography and endoscopic assessment. Metastatic lymph nodes are defined as swollen lymph nodes that are larger than 10 mm in diameter in major axis or 8 mm in diameter in minor axis by CT scan.
3) H0P0M0 and no bulky metastatic lymph nodes (bulky N2) by contrast-enhanced chest - abdominal computed tomography.
4) Clinical T2 located in the U area not invading the greater curvature (Gre).
5) In case without preceding EMR or ESD, the diagnosis is clinical N1-3 or cN0 without indication for EMR(ESD).
6) In case with preceding EMR or ESD, the following conditions are fulfilled: i) pathological findings require additional gastrectomy, ii) within 91 days from EMR or ESD, iii) perforation by EMR or ESD is not considered.
7) Expected R0 surgery
8) Neither Borrmann type 4 nor large (>8cm) type 3
9) No invasion to esophagus and duodenum.
10) Not a stump cancer of stomach
11) Aged 20 years old or older
12) Eastern Cooperative Oncology Group performance status of 0 or 1.
13) Body mass index (BMI) is less than 30.
14) No history of upper abdominal surgery except laparoscopic cholecystectomy.
15) No prior abdominal radiotherapy for any malignancies. History of chemotherapy and/or endocrine therapy is eligible.
16) Adequate organ functions defined as;
i) WBC of 3,000/mm3 or more
ii) Platelet count 100,000/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
17) 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 computed tomography
Target sample size
1040
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Terashima |
Organization
Shizuoka Cancer Center
Division name
Division of Gastric Surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
JCOG_sir@ml.jcog.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Makuuchi |
Organization
JCOG1907 Coordinating Office
Division name
Cancer Institute Hospital of JFCR Department of Gastric Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
03-3520-0111
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）
福島県立医科大学附属病院（福島県）
総合南東北病院（福島県）
埼玉県立がんセンター（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）
順天堂大学医学部附属順天堂医院（東京都）
北里大学医学部（神奈川県）
富山県立中央病院（富山県）
石川県立中央病院（石川県）
山梨県立中央病院（山梨県）
岐阜大学医学部（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）
大阪大学医学部（大阪府）
大阪公立大学医学部附属病院（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）
大阪医科薬科大学（大阪府）
市立豊中病院（大阪府）
神戸大学医学部（兵庫県）
関西労災病院（兵庫県）
兵庫県立がんセンター（兵庫県）
姫路赤十字病院（兵庫県）
和歌山県立医科大学（和歌山県）
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）
広島市立北部医療センター安佐市民病院（広島県）
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）
久留米大学医学部（福岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 16 | 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
| 2020 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045343
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
