UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030505
Receipt number R000034824
Scientific Title TR study of "multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer"
Date of disclosure of the study information 2017/12/21
Last modified on 2023/12/26 10:23:01

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Basic information

Public title

TR study of "multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer"

Acronym

TIRUMPH TR

Scientific Title

TR study of "multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer"

Scientific Title:Acronym

TIRUMPH TR

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To explore biomarker relating to efficacy or resistance of the combination therapy with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor (HER) 2-positive metastatic colorectal cancer who are refractory or intolerant to standard chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cancer-related gene alteration, expression of protein, and expression of RNA

Key secondary outcomes



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

Patients enrolled in treatment group in "multicenter phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer" and who has given written consent for this study

Key exclusion criteria

None

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name Nakamura

Organization

National Cancer Center Hospital East

Division name

BB/TR Support Section, Clinical Research Support Office

Zip code

277-8577

Address

6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan

TEL

04-7133-1111

Email

triumph_core@east.ncc.go.jp


Public contact

Name of contact person

1st name Yoshiaki
Middle name
Last name Nakamura

Organization

National Cancer Center Hospital East

Division name

Department of Gastrointestinal Oncology

Zip code

277-8577

Address

6-5-1,Kashiwanoha,Kashiwa,Chiba, 277-8577,Japan

TEL

04-7133-1111

Homepage URL


Email

triumph_core@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center Hospital East

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

National Cancer Center Institutional Review Board

Address

5-1-1, Tsukiji, Chuo, Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp


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

2017 Year 12 Month 21 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

30

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

No longer recruiting

Date of protocol fixation

2017 Year 09 Month 05 Day

Date of IRB

2017 Year 10 Month 18 Day

Anticipated trial start date

2017 Year 12 Month 20 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2017 Year 12 Month 21 Day

Last modified on

2023 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034824


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name