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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027585
Receipt No. R000031353
Scientific Title Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study
Date of disclosure of the study information 2017/06/19
Last modified on 2019/06/25

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Basic information
Public title Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study
Acronym Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study
(JFMC50-1701-C6)
Scientific Title Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study
Scientific Title:Acronym Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study
(JFMC50-1701-C6)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate a reason for treatment termination of TFTD (such as RECIST PD, PD by imaging beyond RECIST PD, Clinical PD , adverse event, others) by a retrospective cohort study to find which type of cases can obtain long-term survival by TFTD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We compare the difference of the overall survival by each reason (RECIST PD, PD by imaging beyond RECIST PD, Clinical PD , adverse event, others) for termination of TFTD.
Key secondary outcomes Relationship between overall survival and the therapy prior TFTD
Relationship between overall survival and the therapy after TFTD

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 <1st registration>
The metastatic colorectal cancer patients treated with TFTD monotherapy from July 1, 2014 to September 30, 2016.
<2nd registration>
1)Patient with ECOG-PS 0 or 1 at the start of TFTD therapy.
2)Patient older than 19 at the time of registration.
3)Patient who receives TFTD at an initial dose of more than -10mg/day/body.
Key exclusion criteria 1)Patients with active double cancer. Carcinoma in situ (intraepithelial carcinoma) or the intramucosal carcinoma equivalent lesion which are concurrent double cancers and heterochronous double cancers within five years, and the investigator judged to cure by topical treatment, are excluded as the double cancer.
2)Infectious disease to be treated.
3)History of severe comorbidities at the start of TFTD. (severe DM, heart failure over NYHA II degree, renal failure, liver failure etc.).
4)Brain metastasis with clinical symptom who need periodical medication (mannitol and steroid, anticonvulsant).
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)EIJI OKI 2)KENTARO YAMAZAKI
Organization 1)Graduate School of Surgery and Science Kyushu University 2)Shizuoka Cancer Center
Division name 1)Department of Surgery and Science 2)Division of Endoscopy & GI Oncology
Zip code
Address 1)3-1-1 Maidashi, Higashi-ku, Fukuoka City, FUKUOKA, 812-8585, Japan 2)1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, SHIZUOKA,411-8777, Japan
TEL 03-5627-7594
Email jfmc50@jfmc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name EIJI OKI
Organization Graduate School of Surgery and Science Kyushu University
Division name Department of Surgery and Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka City, FUKUOKA, 812-8585, Japan
TEL 092-642-5466
Homepage URL http://www.jfmc.or.jp
Email jfmc50@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
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 06 Month 19 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 02 Month 16 Day
Date of IRB
2017 Year 02 Month 16 Day
Anticipated trial start date
2017 Year 06 Month 19 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of outcome and reason of treatment termination of TFTD for colorectal cancer : A retrospective cohort study
<1st registration>
The metastatic colorectal cancer patients treated with TFTD monotherapy from July 1, 2014 to September 30, 2016.
<2nd registration>
1)Patient with ECOG-PS 0 or 1 at the start of TFTD therapy.
2)Patient older than 19 at the time of registration.
3)Patient who receives TFTD at an initial dose of more than -10mg/day/body.


Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031353

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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