UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014664
Receipt number R000017057
Scientific Title A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer
Date of disclosure of the study information 2014/07/28
Last modified on 2018/07/30 12:03:26

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Basic information

Public title

A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer

Acronym

A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab

Scientific Title

A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab for metastatic colorectal cancer

Scientific Title:Acronym

A phase II study comparing oral S-1 + 24-hour infusion of CPT-11 +bevacizumab with FOLFIRI+bevacizumab

Region

Japan


Condition

Condition

metastatic colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to investigate the efficacy of oral S-1+24-hour infusion of CPT-11+bevacizumab and FOLFIRI+bevacizumab for metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

1 year progression-free survival

Key secondary outcomes

time to progression
response rate
overall survival
adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

standard therapy group (FOLFIRI+bevacizumab)

Interventions/Control_2

trial therapy arm (Oral S-1+24-hour infusion of CPT-11+bevacizumab)

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

metastatic colorectal cancer

Key exclusion criteria

performance status is 2 or 3

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sotaro Sadahiro

Organization

Tokai University

Division name

Deaprtment of Gastrointestinal Surgery

Zip code


Address

143 Shimokasuya Isehara

TEL

0463-93-1121

Email

sadahiro@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sotaro Sadahiro

Organization

Tokai Unversity

Division name

Department of Gastrointestinal Surgery

Zip code


Address

143 Shimokasuya Isehara

TEL

0463-93-1121

Homepage URL


Email

sadahiro@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University, Deaprtment of Gastrointestinal Surgery

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

東海大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2014 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

2013 Year 09 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2017 Year 09 Month 30 Day

Date of closure to data entry

2017 Year 09 Month 30 Day

Date trial data considered complete

2017 Year 09 Month 30 Day

Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 07 Month 27 Day

Last modified on

2018 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name