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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028746
Receipt No. 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

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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
Email 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
Email shouge@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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