UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003398 |
|---|---|
| Receipt number | R000004120 |
| Scientific Title | Prospective study to identify predictive sensitivity of neoadjuvant chemoradiotherapy for locally advanced rectal Cancer (Neoadjuvant-synchronus TS1+RT) |
| Date of disclosure of the study information | 2010/03/29 |
| Last modified on | 2013/09/30 17:20:14 |
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Basic information
Public title
Prospective study to identify predictive sensitivity of neoadjuvant chemoradiotherapy for locally advanced rectal Cancer (Neoadjuvant-synchronus TS1+RT)
Acronym
Prospective study to identify predictive sensitivity of neoadjuvant chemoradiotherapy for rectal Cancer
Scientific Title
Prospective study to identify predictive sensitivity of neoadjuvant chemoradiotherapy for locally advanced rectal Cancer (Neoadjuvant-synchronus TS1+RT)
Scientific Title:Acronym
Prospective study to identify predictive sensitivity of neoadjuvant chemoradiotherapy for rectal Cancer
Region
| Japan |
Condition
Condition
Rectal cancer (Ra, Rb, P) diagnosed as adenocarcinoma and preoperatively diagnosed T3/4 , N0-3.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify predictive sensitivity of locally advanced rectal cancer to preoperative chemoradiiotherapy by microarray analysis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify predictive sensitivity of locally advanced rectal cancer to preoperative chemoradiiotherapy
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
neoadjuvant chemoradiotherapy for locally advanced rectal Cancer
(Neoadjuvant-synchronus TS1+RT)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Rectal cancer (Ra, Rb, P) diagnosed as adenocarcinoma and T3/4, N0-3 preoperatively.
Key exclusion criteria
Cases that have crital drug sensitivity to TS-1 or multiple cacners, multiple colorectal cancers with activity.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Kitano |
Organization
Oita University Faculty of Medicine
Division name
Department of Surgery I
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Oita 879-5593, Japan
TEL
097-586-5843
geka1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Inomata |
Organization
Oita University Faculty of Medicine
Division name
Department of Surgery I
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Oita 879-5593, Japan
TEL
097-586-5843
Homepage URL
geka1@oita-u.ac.jp
Sponsor or person
Institute
Department of Surgery I, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery I, Oita University Faculty of Medicine
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
| 2010 | Year | 03 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004120
