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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003398
Receipt No. 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

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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
Email 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
Email geka1@oita-u.ac.jp

Sponsor
Institute Department of Surgery I, Oita University Faculty of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004120

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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