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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020878
Receipt No. R000024090
Scientific Title Retrospective analysis of hepatic arterial infusion chemotherapy for patients with unresectable liver metastases from colorectal cancer refractory to current standard systemic chemotherapy
Date of disclosure of the study information 2016/02/04
Last modified on 2019/10/24

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Basic information
Public title Retrospective analysis of hepatic arterial infusion chemotherapy for patients with unresectable liver metastases from colorectal cancer refractory to current standard systemic chemotherapy
Acronym Analysis of HAIC for liver metastases from colorectal cancer
Scientific Title Retrospective analysis of hepatic arterial infusion chemotherapy for patients with unresectable liver metastases from colorectal cancer refractory to current standard systemic chemotherapy
Scientific Title:Acronym Analysis of HAIC for liver metastases from colorectal cancer
Region
Japan

Condition
Condition liver metastases from colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the utility of hepatic hepatic arterial infusion chemotherapy for patients with unresectable liver metastases from colorectal cancer refractory to current standard systemic chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival time from initiation of hepatic arterial infusion chemotherapy
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with unresectable liver metastases from colorectal cancer
2) Patients who had undergone standard systemic chemotherapy for advanced or metastatic colorectal cancer
3) Patients receiving hepatic hepatic arterial infusion chemotherapy after standard systemic chemotherapy
Key exclusion criteria 1) Active double cancers
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Inaba
Organization Aichi Cancer Center Hospital
Division name Department of Diagnostic and Interventional Radiology
Zip code 4648681
Address 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL 052-762-6111
Email 105824@aichi-cc.jp

Public contact
Name of contact person
1st name Yozo
Middle name
Last name Sato
Organization Aichi Cancer Center Hospital
Division name Department of Diagnostic and Interventional Radiology
Zip code 4648681
Address 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL 052-762-6111
Homepage URL
Email ysato@aichi-cc.jp

Sponsor
Institute Japanese Society of Implantable Port Assisted Treatment
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Aichi Cancer Center IRB
Address 1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi
Tel 052-762-6111
Email irb@aichi-cc.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 愛知県がんセンター中央病院(愛知県)、静岡県立静岡がんセンター(静岡県)、群馬大学病院(群馬)、神戸医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 04 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 Completed
Date of protocol fixation
2016 Year 01 Month 29 Day
Date of IRB
2016 Year 01 Month 29 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 05 Month 01 Day

Other
Other related information Investigation object:
Patients who met the selection criteria from September 2008 to December 2015

Evaluation items:
1) Overall survival time from initiation of hepatic arterial infusion chemotherapy
2) Treatment duration with hepatic arterial infusion chemotherapy
3) Objective response rate
4) Disease control rate
5) Exploring the factors that affect the treatment effects
6) Incidence and grade of adverse events

Management information
Registered date
2016 Year 02 Month 04 Day
Last modified on
2019 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024090

Research Plan
Registered date File name
2018/02/05 肝動注調査 プロトコール.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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