UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028746 |
|---|---|
| Receipt number | R000032896 |
| Scientific Title | Phase II study of lAParoscopic colectomy for TRansverse and descending colon cancer |
| Date of disclosure of the study information | 2017/08/19 |
| Last modified on | 2017/08/19 19:12:38 |
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Basic information
Public title
Phase II study of lAParoscopic colectomy for TRansverse and descending colon cancer
Acronym
ACC-TRAP
Scientific Title
Phase II study of lAParoscopic colectomy for TRansverse and descending colon cancer
Scientific Title:Acronym
ACC-TRAP
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and efficacy of laparoscopic colectomy for resectable transverse and descending colon cancer earlier than T3 and N1 without distant metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
postoperative complication rate
Key secondary outcomes
operation time, blood loss, intraoperative complication, conversion rate to open surgery, hospital stay after operation, resection plane, disease free survival, overall survival
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
laparoscopic surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) pathologically diagnosed as colon cancer
2) located at transverse or descending colon
3) disease with T1-3, N0, M0 (TMN classification) by preoperative radiological diagnosis
4) without multiple colon cancer
5) without preoperative treatment for any cancer including chemotherapy and radiotherapy
6) without history of preceding colectomy
7) good general condition
8) obtained signature for participating this study
Key exclusion criteria
nothing
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shimizu |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
Kanokoden 1-1 Chikusa-ku Nagoya 464-8681, Japan
TEL
052-762-6111
shouge@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ouchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
Kanokoden 1-1 Chikusa-ku Nagoya 464-8681, Japan
TEL
052-762-6111
Homepage URL
shouge@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center
Organization
Division
Category of Funding Organization
Local Government
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 19 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 19 | Day |
Last modified on
| 2017 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032896
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