UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of lAParoscopic colectomy for TRansverse and descending colon cancer
Title of the study (Brief title)	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	Yasuhiro Shimizu
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
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	Akira Ouchi
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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