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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001704
Receipt No. R000002030
Scientific Title A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Date of disclosure of the study information 2009/02/17
Last modified on 2012/02/13

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Basic information
Public title A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Acronym A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Scientific Title A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Scientific Title:Acronym A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Region
Japan

Condition
Condition rectal cancer,lower tumor margin is below the peritoneal reflection
Classification by specialty
Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes pathological complete response rate
pathological response rate
adverse event
overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT 300mg/m2/day 1-5,8-12,15-19,22-26
Radiotherapy 2gy 5days a week for 4weeks
Interventions/Control_2 -1 80mg/m2/day 1-5,8-12,15-19,22-26
Radiotherapy 2gy 5days a week for 4weeks
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1,histologically confirmed rectal cancer
2,clinical stage T1-T4 for EUS or CT
3,lower tumor margin is below the peritonal reflection
4,weasurable resion
5,no evidence of peritoneal metastasis
6,age 20-74 years old
7,performance status(ECPG) 0-2
8,possible to 3month survival
9,adequate organ function
10,no prior oparation,chemotherapy,radiotherapy
11,written informed concent
12,the case can eat
Key exclusion criteria 1,apparent or previous history of interstitinal pneumonitis or pulmonary fibrosis
2,pleural effusion or ascites requiring treatment
3,multiple malignancies
4,infection,paralysis of intestine or ireus
5,diarrhea(watery stool)
6,uncontrollacle diabetes
7,severe complication(heart failure,renal failure,hepatic insufficiency)
8,brain metastasis or treated brain metastasis
9,preqnant or lacting,capable of preqnancy or intend to get preqnant
10,previus serius medical illness or allergy for drug
11,critical mental disturbance
12,systemically administrered of steroids
13,judged in appropriate for this study by the physycians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Shimada
Organization Tokushima university
Division name Department of surgery and transplantation
Zip code
Address 3-18-15 Kuramoto, Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima university
Division name Department of surgery and transplantation
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tokushima university
Institute
Department

Funding Source
Organization Taiho pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 02 Month 17 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
2008 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 13 Day
Last modified on
2012 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002030

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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