UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031233
Receipt number R000035663
Scientific Title A clinical study of CapeOX+Cetuximab as first line therapy in patents with KRAS/BRAF wild type metastatic colorectal cancer (A pooled analysis of FLEET and FLEET2 study)
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/09 19:19:39

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Basic information

Public title

A clinical study of CapeOX+Cetuximab as first line therapy in patents with KRAS/BRAF wild type metastatic colorectal cancer
(A pooled analysis of FLEET and FLEET2 study)

Acronym

A pooled analysis of FLEET and FLEET2 study

Scientific Title

A clinical study of CapeOX+Cetuximab as first line therapy in patents with KRAS/BRAF wild type metastatic colorectal cancer
(A pooled analysis of FLEET and FLEET2 study)

Scientific Title:Acronym

A pooled analysis of FLEET and FLEET2 study

Region

Japan


Condition

Condition

metastatic colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of CapeOX+Cetuximab as first line therapy in patient with KRAS/BRAF wild type for metaststic colorectal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression free survival


Base

Study type

Others,meta-analysis etc


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients treated by CapeOx+Cetuximab
in FLEET and FLEET2 study

Key exclusion criteria

nane

Target sample size

65


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name shigeyoshiiwamoto

Organization

Aichi medical University

Division name

Cancer center

Zip code


Address

YazakoKarimata 1-1 Nagakute, Aichi, JAPAN

TEL

0561-62-3311

Email

iwamoto.shigeyoshi.168@mail.aichi-med-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name shigeyoshiiwamoto

Organization

Aichi medical University

Division name

Cancer center

Zip code


Address

YazakoKarimata 1-1 Nagakute, Aichi, JAPAN

TEL

0561-62-3311

Homepage URL


Email

iwamoto.shigeyoshi.168@mail.aichi-med-u.ac.jp


Sponsor or person

Institute

The nonprofit organization
Epidemiological & Clinical Research Organization.

Institute

Department

Personal name



Funding Source

Organization

The nonprofit organization
Epidemiological & Clinical Research Organization.

Organization

Division

Category of Funding Organization

Other

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

2018 Year 03 Month 01 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

Preinitiation

Date of protocol fixation

2018 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A pooled analysis of FLEET and FLEET2 study


Management information

Registered date

2018 Year 02 Month 09 Day

Last modified on

2018 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=R000035663


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name