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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027211
Receipt No. R000031179
Scientific Title A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies, accompanying research(WJOG8916GTR)
Date of disclosure of the study information 2017/05/01
Last modified on 2017/06/20

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Basic information
Public title A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies, accompanying research(WJOG8916GTR)
Acronym A phase II trial of TAS-102 in combination with cetuximab for metastatic colorectal cancer patients, accompanying research(WJOG8916GTR)
Scientific Title A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies, accompanying research(WJOG8916GTR)
Scientific Title:Acronym A phase II trial of TAS-102 in combination with cetuximab for metastatic colorectal cancer patients, accompanying research(WJOG8916GTR)
Region
Japan

Condition
Condition Metastatic RAS wild type colorectal cancer which has become refractory or there was intolerance to chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin) and bevacizumab, and refractory to anti- epidermal growth factor receptor(EGFR) antibodies
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to reveal the biomarker of TAS-102 in combination with cetuximab for patients with metastatic RAS wild type colorectal cancer
Basic objectives2 Others
Basic objectives -Others To explore effect predictor
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The biomarker of TAS-102 in combination with cetuximab
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 who agreed to this study in patients who participated a phase II trial of TAS-102 in combination with cetuximab
Key exclusion criteria None
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Izawa
Organization St. Marianna University School of Medicine
Division name Department of Clinical Oncology
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511
TEL 044-977-8111
Email n2izawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
2017 Year 05 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to reveal the biomarker of TAS-102 in combination with cetuximab for patients with metastatic RAS wild type colorectal cancer

Management information
Registered date
2017 Year 05 Month 01 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031179

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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