UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005421 |
|---|---|
| Receipt number | R000006431 |
| Scientific Title | Randomized phase II study of omentum-preserving gastrectomy for advanced gastric cancer |
| Date of disclosure of the study information | 2011/04/11 |
| Last modified on | 2022/03/16 09:55:06 |
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Basic information
Public title
Randomized phase II study of omentum-preserving gastrectomy for advanced gastric cancer
Acronym
omentum-preserving gastrectomy for advanced gastric cancer
Scientific Title
Randomized phase II study of omentum-preserving gastrectomy for advanced gastric cancer
Scientific Title:Acronym
omentum-preserving gastrectomy for advanced gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the results of omentum-preserving gastrectomy for advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year relapse-free survival rate
Key secondary outcomes
five year survival rate
loss of blood volume
operative duration
operative morbidity rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
Complete resection of the omentum
Interventions/Control_2
Preservation of the omentum except for the site along the gastroepiploic artery
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
first registration
1) Histologically proven gastric cancer
2) Diagnosed in preoperative study for cT2(MP)-, cN0-2, cM0
3) Expected to achieve the R0 resection by total/distal gastrectomy
4) Non-Type4
5) No history of receiving the transabdominal surgery, except for the surgery for appendicitis and the laparoscopic chelecystectomy
6) Not received neoadjuvant chemotherapy
7) No history of receiving gastrectomy
8) An age of 20 years or more
9) ECOG-PS 0-2
10) An adequate organ function
11) Written informed consent
second registration
1) MP-SE, N0-2, H0, P0, M0 in surgical findings
2) Expected to achieve the R0 or R1(CY1) resection by total/distal gastrectomy
3) Expected to achieve the resection of the omentum
4) Not required the transthoracic surgery
Key exclusion criteria
1) The history of unstable angina, or myocardial infarction occurred in 6 months
2) Diabetes Mellitus with poor control
3) Required the oxygen administration due to severe respiratory disease
4) The history of severe drug allergic reaction
5) Acute inflammatory disease
6) Pregnant female
7) Another malignant disease
8) The history of mental disease
9) Not appropriate for the trial by other reasons
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Yamamoto |
Organization
Fujisawa Shounandai Hospital
Division name
surgery
Zip code
252-0802
Address
2345 Takakura Fujisawa-city, Kanagawa Prefecture, 252-0802, Japan
TEL
0466-44-1451
y_yamamoto@fj-shounandai.or.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Yamada |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
TEL
045-520-2222
Homepage URL
takay0218@yahoo.co.jp
Sponsor or person
Institute
Fujisawa Shounandai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center Ethics Committee
Address
2-3-2 Nakao, Asahi-ku, Yokohama City, 241-8515, Japan
Tel
045-520-2222
u_syomu@yokohama-cu.ac.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
神奈川県立足柄上病院（神奈川県）
恵生会 上白根病院（神奈川県）
国際医療福祉大学 熱海病院（静岡県）
国家公務員共済組合連合会 平塚共済病院（神奈川県）
国家公務員共済組合連合会 横浜南共済病院（神奈川県）
総合病院 秦野赤十字病院（神奈川県）
同友会 藤沢湘南台病院（神奈川県）
三浦市立病院（神奈川県）
横浜市立大学附属病院（神奈川県）
済生会横浜市南部病院（神奈川県）
神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 11 | 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
251
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
| 2010 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006431
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