UMIN-CTR Clinical Trial

Basic information
Public title	Oncological outcomes of repeat metastasectomy for recurrence after hepatectomy for colorectal liver metastases.
Acronym	Repeat metastasectomy for colorectal metastases.
Scientific Title	Oncological outcomes of repeat metastasectomy for recurrence after hepatectomy for colorectal liver metastases.
Scientific Title:Acronym	Repeat metastasectomy for colorectal metastases.
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to clarify the oncological outcomes of repeat metastasectomy for recurrence to various organs after hepatectomy for colorectal liver metastases and to determine the prognostic factors after repeat surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Oncological outcomes of repeat metastasectomy for recurrence to various organs after hepatectomy for colorectal liver metastases.
Key secondary outcomes	To determine the prognostic factors after repeat surgery.

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	21 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Recurrence after hepatectomy for colorectal liver metastases.
Key exclusion criteria	R0 resection is not possible.
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Maeda
Organization	Hokkaido Cancer Center
Division name	Dept. of Surgery
Zip code	003-0804
Address	4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN
TEL	011-811-9111
Email	maeda19671101@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshiaki Middle name Last name Maeda
Organization	Hokkaido Cancer Center
Division name	Det. of Curgery
Zip code	003-0804
Address	4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN
TEL	0118119111
Homepage URL
Email	maeda19671101@yahoo.co.jp

Sponsor
Institute	Hokkaido Cancer Center
Institute
Department

Funding Source
Organization	Hokkaido Cencer Center
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido Cancer Center
Address	4-2-3-54 Kikusui, Shiroishi, Sapporo, 003-0804 JAPAN
Tel	0118119111
Email	maeda19671101@yahoo.co.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	2019 Year 09 Month 04 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	130
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	2019 Year 07 Month 03 Day
Date of IRB	2019 Year 07 Month 03 Day
Anticipated trial start date	2019 Year 07 Month 03 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	None

Management information
Registered date	2019 Year 09 Month 04 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043238