UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007415
Receipt No. R000008735
Scientific Title Chemoradiation therapy after endoscopic resection for rectal carcinoma
Date of disclosure of the study information 2012/03/01
Last modified on 2017/03/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Chemoradiation therapy after endoscopic resection for rectal carcinoma
Acronym CRT after EMR for rectal carcinoma
Scientific Title Chemoradiation therapy after endoscopic resection for rectal carcinoma
Scientific Title:Acronym CRT after EMR for rectal carcinoma
Region
Japan

Condition
Condition rectal carcinoma
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Study of chemoradiation therapy after endoscopic resection for rectal carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes rate of recurrence and suuvival time
Key secondary outcomes 1)pathological findings of SM carcinoma
2)total dose of TS-1
3)total dose of radiation
4)site of recurrence, type of recurrence
5)survival rate, disease-free survival
6)adverse event

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
Medicine
Interventions/Control_1 We study alternate treatment for rectal cancer which was resected endoscopically.
TS-1 and radiation(total 45Gy) are replaced by the administration of surgical operation.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.rectal carcinoma(Rb)
2.lesion was resected by endoscopically.
3.indication of radical surgical resection
4.no metastasis in kickoff point
5.tolerable condition for chemoradiation
6.give informed consent
Key exclusion criteria 1.not satisfy selection criteria
2.drug allergy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Tomiki
Organization Juntendo University, Faculty of Medicine
Division name Department of Coloproctological Surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo,113-8421, Japan
TEL 03-3813-3111
Email tomiki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Tomiki
Organization Juntendo University
Division name Department of Coloproctological Surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email tomiki@juntendo.ac.jp

Sponsor
Institute Juntendo University, Faculty of Medicine
Institute
Department

Funding Source
Organization Juntendo University, Faculty of Medicine
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
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
2012 Year 03 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
2012 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 03 Month 01 Day
Last modified on
2017 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.