UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001704 |
|---|---|
| Receipt number | 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 09:12:22 |
* 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
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
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
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002030
