UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037206 |
|---|---|
| Receipt number | R000042374 |
| Scientific Title | Organ preserving strategy "Watch and Wait" for rectal adenocarcinoma acheived clinical complete response treated with chemoradiotherapy |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/07/03 15:27:18 |
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Basic information
Public title
Organ preserving strategy "Watch and Wait" for rectal adenocarcinoma acheived clinical complete response treated with chemoradiotherapy
Acronym
Watch and Wait trial
Scientific Title
Organ preserving strategy "Watch and Wait" for rectal adenocarcinoma acheived clinical complete response treated with chemoradiotherapy
Scientific Title:Acronym
Watch and Wait trial
Region
| Japan |
Condition
Condition
low rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess organ preserving rate of patient treated with watch and wait strategy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
organ preserving rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
watch and wait strategy
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
low rectal adenocarcinoma
clinical complete response by chemoradiothrapy
assessment was conducted 10-12 weeks after chemoradiotherapy. clinical complete response fulfilled all criteria:the absence of residual ulceration, mass, mucosal irregularity at digital examination and endoscopic assessment. no evidence of residual disease at CT and MRI.
Key exclusion criteria
patients who are not to be able to understand the study and sign the informed consent to participate due to any reasons
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hisahiro |
| Middle name | |
| Last name | Matsubara |
Organization
Graduate school of medicine,Chiba university
Division name
Department of Frontier Surgery
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba,Japan
TEL
043-226-2109
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Imanishi |
Organization
Graduate school of medicine, Chiba university
Division name
Department of Frontier
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba,Japan
TEL
043-226-2109
Homepage URL
shun_imanishi@chiba-u.jp
Sponsor or person
Institute
Chiba University hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University hospital
Address
1-8-1,Inohana Chuo-ku,Chiba,Japan
Tel
043-222-7171
prc-jm@chiba-u.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
| 2019 | Year | 09 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042374
| Research Plan | |
|---|---|
| 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 |
