UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027585 |
|---|---|
| Receipt number | 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 17:36:06 |
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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
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
jfmc50@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031353
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
