UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020878 |
|---|---|
| Receipt number | 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 14:30:41 |
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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
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
ysato@aichi-cc.jp
Sponsor or person
Institute
Japanese Society of Implantable Port Assisted Treatment
Institute
Department
Personal name
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
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
Value
https://center6.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 |
