UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027211 |
|---|---|
| Receipt number | 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 | 2022/11/07 10:09:16 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 19 | Day |
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
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031179
