UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011164
Receipt number 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 09:15:32

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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 or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



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

Value
https://center6.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