UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000874 |
|---|---|
| Receipt number | R000001027 |
| Scientific Title | A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703) |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2014/04/30 11:59:11 |
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Basic information
Public title
A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703)
Acronym
A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703)
Scientific Title
A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703)
Scientific Title:Acronym
A phase II study of laparoscopy assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0703)
Region
| Japan |
Condition
Condition
clinical stage I gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of laparoscopy assisted distal gastrectomy (LADG) with nodal dissection for clinical stage IA or IB gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of anastomotic leakage or pancreatic fistula
Key secondary outcomes
overall survival, recurrence-free survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes
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
Laparoscopy assisted distal gastrectomy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma.
2) cStage IA or IB.
3) No indication of endoscopic mucosal resection (EMR) in a cN0 case.
4) Tumor located in the middle or lower 1/3 of the stomach and indication for distal gastrectomy.
5) No invasion to duodenum.
6) Aged 20 to 80 year.
7) PS (ECOG) of 0 or 1.
8) Body mass index <30.
9) Not recurrence after EMR.
10) No history of upper abdominal surgery and no history of intestinal resection.
11) No prior treatment of chemotherapy or radiation therapy against any other malignancies.
12) Sufficient organ functions.
13) 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
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Katai |
Organization
National Cancer Center Hospital
Division name
Division of Gastric Surgery
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Katai |
Organization
JCOG0703 Coordinating Office
Division name
Division of Gastric Surgery, National Cancer Center Hospital
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
03-3542-2511
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
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
国立病院機構仙台医療センター（宮城県）
山形県立中央病院（山形県）
国立がんセンター中央病院（東京都）
東京医科歯科大学（東京都）
癌研究会有明病院（東京都）
都立墨東病院（東京都）
神奈川県立がんセンター（神奈川県）
静岡県立総合病院（静岡県）
愛知県がんセンター中央病院（愛知県）
藤田保健衛生大学（愛知県）
近畿大学医学部（大阪府）
大阪府立病院機構大阪府立成人病センター（大阪府）
大阪医科大学（大阪府）
和歌山県立医科大学（和歌山県）
広島市立広島市民病院（広島県）
大分大学医学部附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/21128059
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
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
Main results already published
Date of protocol fixation
| 2007 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001027
