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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011164
Receipt No. R000013076
Scientific Title Hepatectomy + XELOX for Liver Metastasis of Colorectal Cancer.
Date of disclosure of the study information 2013/07/20
Last modified on 2019/02/09

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Basic information
Public title Hepatectomy + XELOX for Liver Metastasis of Colorectal Cancer.
Acronym adjXELOX study
Scientific Title Hepatectomy + XELOX for Liver Metastasis of Colorectal Cancer.
Scientific Title:Acronym adjXELOX study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 feasibility of adjuvant XELOX for post curative resection of liver metastasis from colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes completion rate of adjuvant chemotherapy
Key secondary outcomes OS,PFS,AE,recurrence,dose-intensity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 adjuvant Xeloda followed by XELOX total 5 course after curative resection of liver metastasis from colorectal carcinoma.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)histlogically proven colorectal carcinoma
2)Curatively resected metastatic liver tumors form colorectal cancer
3)No extrahepatic sites of disease
4)wihtin 90 days from the date of liver resection
5)age >= 20 years
6)Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1
7)No prior chemotherapy and radiotherapy to the liver
8)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
9)Written informed consent
Key exclusion criteria 1) active synchronous or metachronous malignancy other than carcinoma in situ
2) pregnant or nursing
3) severe mental disorders
4) systemic steroid user
5) diabetes mellitus, uncontrolled or controlled with insulin
6) history of myocardial infarction, unstable angina within 3 months prior to the registration
7) serious coexisting illness
8) active infection
9) peripheral neuropathy greater than Grade 2

Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Tsuji
Organization Kobe City Medical Center General Hospital
Division name medical oncology
Zip code
Address 2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL 0783024321
Email hsatake@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironaga Satake
Organization Kobe City Medical Center General Hospital
Division name medical oncology
Zip code
Address 2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL 0783024321
Homepage URL
Email takeh1977@gmail.com

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor Kobe City Medical Center West Hospital,Nishikobe Medical Center,Takarazuka city hospital,Himeji red cross hospital,Nishinomiya Hospital et al.
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
2013 Year 07 Month 20 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 Main results already published
Date of protocol fixation
2013 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2019 Year 04 Month 30 Day
Date trial data considered complete
2019 Year 04 Month 30 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 10 Day
Last modified on
2019 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013076

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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