UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022276
Receipt number R000025668
Scientific Title A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer
Date of disclosure of the study information 2016/05/12
Last modified on 2016/11/14 14:57:17

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Basic information

Public title

A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer

Acronym

A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer

Scientific Title

A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer

Scientific Title:Acronym

A multicenter observational study of TAS-102 and regorafenib in patients with metastatic colorectal cancer

Region

Japan


Condition

Condition

Metastatic colorectal cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of TAS-102 and Regorafenib in patients with metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EuroQol 5 Dimension-5L (EQ5D-5L)

Key secondary outcomes

Quality-adjusted life year (QALY)
Incremental cost-utility ratio (ICUR)
Progression free survival (PFS)
Overall survival (OS)
Response rate (RR)
Disease control rate (DCR)
Safety
To investigate the reason for treatment selection
Analysis of factor what patients were unable to choose the treatment by themselves


Base

Study type

Observational


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

1. Histologically proven Adenocarcinoma
of colorectal cancer
2. Prior chemotherapy with more than two regimens
3. Written informed consent
4. Age under 20 years old at the time of informed consent
5. Patients are able to take medications orally.

Key exclusion criteria

1. Prior therapy with TAS-102 or regorafenib
2. Inappropriate for the study in the option of the investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin Sasaki

Organization

Omori Red Cross Hospital

Division name

Surgery

Zip code


Address

4-30-1, Chuo, Ota-ku, Tokyo

TEL

03-3775-3111

Email

s-sasaki@omori.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ethics committee

Organization

Omori Red Cross Hospital

Division name

Ethics committee

Zip code


Address

4-30-1, Chuo, Ota-ku, Tokyo

TEL

03-3775-3111

Homepage URL


Email

jinji@omori.jrc.or.jp


Sponsor or person

Institute

Omori Red Cross Hospital

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

2016 Year 05 Month 12 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

Date of protocol fixation

2015 Year 08 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 10 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

according to the protocol


Management information

Registered date

2016 Year 05 Month 11 Day

Last modified on

2016 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025668


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name