UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040763 |
|---|---|
| Receipt number | R000046549 |
| Scientific Title | Oncologic outcomes of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/06/16 07:22:26 |
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Basic information
Public title
Oncologic outcomes of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer
Acronym
Oncologic outcome of Lap-CME with D3 for T3/T4a colorectal cancer
Scientific Title
Oncologic outcomes of laparoscopic surgery in complete mesocolic excision with D3 lymph node dissection for T3/4a colon cancer
Scientific Title:Acronym
Oncologic outcome of Lap-CME with D3 for T3/T4a colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Oncologic outcome of Laparoscopic CME with D3
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year-recurrence free survival
Key secondary outcomes
5-year overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
T3/T4a colorectal cancer
R0 resection
Key exclusion criteria
synchronous malignancies, emergency surgery, appendiceal tumor, familial tumor (familial adenomatous polyposis or lynch syndrome), inflammatory bowel disease,neuroendocrine tumor, and D2 lymph node dissection
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Konishi |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
+81-3-3520-0111
tkonishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Konishi |
Organization
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
+81-3-3520-0111
Homepage URL
tetsuro.tominaga@nagasaki-u.ac.jp
Sponsor or person
Institute
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
None
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
Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
Tel
+81-3-3520-0111
tetsuro.tominaga@nagasaki-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 15 | 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
1191
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we aimed to examine the oncological safety of laparoscopic CME with D3 dissection for pT3/4a colon cancer, and to examine whether increased use of a laparoscopic approach changed the outcomes in a cohort at a comprehensive cancer center.
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046549
| 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 |
