UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003961
Receipt number R000004771
Scientific Title XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy
Date of disclosure of the study information 2010/07/28
Last modified on 2011/08/01 11:55:02

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Basic information

Public title

XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy

Acronym

XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy

Scientific Title

XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy

Scientific Title:Acronym

XELOX(+bevacizumab), efficacy, safety, QOL Study:FOLFOX(+bevacizumab) after starting therapy, for patients can't continue continuous infusion therapy

Region

Japan


Condition

Condition

advanced and recurrent colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy, safety of XELOX for patients can't continue continuous infusion therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

FOLFOX(+bevacizumab) from PFS

Key secondary outcomes

safety,cycle number of XELOX,Quolity of life(FACT-C)


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

1000mg/m2 of oral Xeloda twice daily on days 1 through 14 every 3 weeks.
L-OHP 130mg/m2 is administered intravenous injection on day 1.
(Bevacizumab 7.5mg/kg is administered intravenous injection on day 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Pathologically proved colorectal cancer
2)Age at registration is above 20
3)ECOG Performance status is 0 or 1
4)FOLFOX in treatment(or at least SD)but problems such as continuous infusion of impossible to continue treating patients, Identified as difficult cases at the request of the patient continuous infusion
5)Intake of normal diet and oral drugs is possible
6)With advanced or recurrent measurable disease,colon or rectal cancer
7)At least two cycles or XELOX(+bevacizumab)treatment for possible
8)Written informed consent is taken

Key exclusion criteria

1)severe renal failure
2)severe hypersensitivity to have a history fluorouracil,lebohorinatokarushiumu, platinum, bevacizumab
3)activity with multiple cancers(After which no more than five years of activity)
4)brain metastases(only when using bevacizumab)
5)FOLFOX(+bevacizumab)treatment for 3 or more months after
6)In addition, if deemed unsuitable to participate in this study is the responsible physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihito Tsuji

Organization

Kochi Health Sciences Center

Division name

Department of Medical Oncology

Zip code


Address

2125-1 Ike, Kochi-city,Kochi,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Akihito Tsuji

Organization

Kochi Health Sciences Center

Division name

Department of Medical Oncology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Kochi Health Sciences Center

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


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

2010 Year 07 Month 28 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

2010 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date

2011 Year 07 Month 01 Day

Date of closure to data entry

2011 Year 07 Month 01 Day

Date trial data considered complete

2011 Year 07 Month 01 Day

Date analysis concluded

2011 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 07 Month 28 Day

Last modified on

2011 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004771


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name