UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013494 |
|---|---|
| Receipt number | R000015766 |
| Scientific Title | Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer. Clinical significance of additional systemic chemotherapy before surgery. |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2018/03/27 09:31:58 |
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Basic information
Public title
Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer. Clinical significance of additional systemic chemotherapy before surgery.
Acronym
Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer.
Scientific Title
Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer. Clinical significance of additional systemic chemotherapy before surgery.
Scientific Title:Acronym
Preoperative chemoradiotherapy with oral S-1 and UFT/LV for stage II/III rectal cancer.
Region
| Japan |
Condition
Condition
Stage II /Stage III rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
developement of an optimal preoperative chemoradiotherapy for rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
rate of pCR (pathological complete regression)
Key secondary outcomes
Tumor regression grading, rate of R0 resection, rate of daownstaging, Disease-free survival, Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard therapy group 1 (4 weeks of S-1)
Interventions/Control_2
Trial therapy group 1 (8 weeks of S-1)
Interventions/Control_3
Standard therapy group 2 (5 weeks of UFT/LV)
Interventions/Control_4
Trial therapy group 2 (10 weeks of UFT/LV)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
clinical Stage II/III rectal cancer
Key exclusion criteria
emergency surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sotaro Sadahiro |
Organization
Tokai University
Division name
gastrointestinal surgery
Zip code
Address
143 Shimokasuya Isehara
TEL
0463-93-1121
sadahiro@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sotaro Sadahiro |
Organization
Tokai University
Division name
Gastrointestinal Surgery
Zip code
Address
143 Shimokasuya Isehara
TEL
0463-93-1121
Homepage URL
sadahiro@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University, Department of Gastrointestinal Surgery
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
東海大学付属病院 (神奈川県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 24 | 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
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015766
