UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003420 |
|---|---|
| Receipt number | R000004144 |
| Scientific Title | Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) |
| Date of disclosure of the study information | 2010/03/31 |
| Last modified on | 2022/04/10 14:52:45 |
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Basic information
Public title
Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Acronym
Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Scientific Title
Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Scientific Title:Acronym
Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate oncological outcome of patients for advanced gastric cancer undergoing laparoscopic versus open surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
phaseII: Incidence of anastomotic leakage or pancreatic fistula
phaseIII:relapse-free survival
Key secondary outcomes
overall survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, number of retrieved lymph node, recurrent sites
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: Open distal gastrectomy with D2 lymph node dissection
Interventions/Control_2
B: Laparoscopy assisted distal gastrectomy with D2 lymph node 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
For inclusion in the study, patients must fulfill the following requirements preoperatively:
1) histologically proven gastric carcinoma
2) MP,SS or deeper lesion without involvement of other organs, N0-2 excluding bulky N2 and M0 according to the Japanese classification system
3) tumor located in the body and antrum of the stomach and indication for distal gastrectomy
4)No invasion to duodenum
5) Aged 20 to 80 year
6) PS (ECOG)0 or 1
7) Body mass index < 30
8) no history of gastrointestinal surgery
9) no history of chemotherapy or radiotherapy
10) Sufficient organ functions
11) provided written informed consent
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
2) Women during pregnancy or breast-feeding.
3) Severe mental disease.
4) Continuous systemic steroid therapy.
5) History of myocardial infarction or unstable angina pectoris within six months.
6) Uncontrollable hypertension.
7) Uncontrollable diabetes millutus or administration of insulin.
8) Severe respiratory disease requiring continuous oxygen therapy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Kitano |
Organization
Japanese Laparoscopic Surgery Study Group (JLSSG)
Division name
Oita University
Zip code
Address
1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
097-586-5843
geka1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Etoh |
Organization
Japanese Laparoscopic Surgery Study Group (JLSSG) Coordinating Office
Division name
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Zip code
Address
1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
097-586-5843
Homepage URL
geka1@oita-u.ac.jp
Sponsor or person
Institute
Japanese Laparoscopic Surgery Study Group (JLSSG)
Institute
Department
Personal name
Funding Source
Organization
Japanese Laparoscopic Surgery Study Group (JLSSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
大分大学医学部消化器・小児外科（大分県）
佐賀大学医学部附属病院一般・消化器外科（佐賀県）
福岡大学病院消化器外科（福岡県）
兵庫県立がんセンター消化器外科（兵庫県）
岩手医科大学外科（岩手県）
大阪医科大学一般・消化器外科（大阪府）
大阪大学医学部附属病院消化器外科（大阪府）
泉大津市立病院外科・内視鏡外科（大阪府）
名古屋大学医学部附属病院消化器外科（愛知県）
岐阜大学腫瘍外科（岐阜県）
長野市民病院外科（長野県）
慶應義塾大学病院外科（東京都）
東京医科歯科大学大学院腫瘍外科（東京都）
駿河台日本大学病院外科（東京都）
北里大学東病院外科（神奈川県）
石川県立中央病院消化器外科（石川県）
富山県済生会高岡病院外科（富山県）
函館五稜郭病院外科（北海道）
聖マリアンナ医科大学(東京都）
大阪市立総合医療センター消化器外科（大阪府）
福井県済生会病院外科（福井県）
九州大学臨床・腫瘍外科（福岡県）
愛媛大学消化管・腫瘍外科(愛媛県）
横浜市立大学附属市民総合医療センター消化器病センター（神奈川県）
岡山大学消化管外科（岡山県）
埼玉医科大学国際医療センター上部消化管外科（埼玉県）
静岡県立静岡がんセンター胃外科（静岡県）
愛知県がんセンター消化器外科（愛知県）
神戸大学食道・胃腸外科（兵庫県）
新潟市民病院消化器外科（新潟県）
がん・感染症センター都立駒込病院外科（東京都）
近畿大学外科学内視鏡外科部門（大阪府）
大阪市立大学腫瘍外科（大阪府）
国立がん研究センター東病院胃外科（千葉県）
佐賀県医療センター好生館消化器外科（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | 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
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
| 2009 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004144
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