UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009326 |
|---|---|
| Receipt number | R000010842 |
| Scientific Title | Switch maintenance using UFT/LV therapy after Oxaliplatin based adjuvant chemotherapy for StageIV colorectal cancer |
| Date of disclosure of the study information | 2012/11/14 |
| Last modified on | 2020/05/20 09:19:16 |
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Basic information
Public title
Switch maintenance using UFT/LV therapy
after Oxaliplatin based adjuvant chemotherapy for StageIV colorectal cancer
Acronym
FUTURE1203(SWIM IV)
Scientific Title
Switch maintenance using UFT/LV therapy
after Oxaliplatin based adjuvant chemotherapy for StageIV colorectal cancer
Scientific Title:Acronym
FUTURE1203(SWIM IV)
Region
| Japan |
Condition
Condition
StageIV patients with curative resection for colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of switch maintenance using UFT plus LV after Oxaliplatin based adjuvant chemotherapy for stageIV cololectal cancer with resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The complete of treatment,Safety
Key secondary outcomes
3year overall survival rate
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
Within 8 weeks after Oxaliplatin based
chemotherapy
(UFT/LV Switch maintenance:5 course)
UFT/LV p.o:4weeks on 1week off
to be repeated every 5weeks
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
1.Patients with curative resection for stageIV colorectal cancer
2.Patients recieved Oxaliplatin based
chemotherapy
3.Possible patients using UFT/LV maintenance therapy
4.Age:20years to 80years
5.Performance Status:0-1
6.Patients sighed informed consent
7.Vital organ functions are preserved
wiyhin 14days prior to entry
Key exclusion criteria
1.Prior severe drug allergy
2.Nursing or pregnant females, or females
or mailes with partners who are planning
pregnancy
3.Presence of active infection
4.Serious complications
5.Inadequate cases for study enrollment
by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoichiro |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka University Faculty of Medcine
Division name
Department of Gastroenterological Surgery
Zip code
8190013
Address
7-45-1,Nanakuma,Johnan-ku,Fukuoka,814-0180,Japan
TEL
+928011011
yyoshida@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
8190013
Address
7-45-1,Nanakuma,Johnan-ku,Fukuoka,814-0180,Japan
TEL
+928011011
Homepage URL
yyoshida@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka Tumor Research(FUTURE)
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukuoka Univesity
Address
7-45-1, Nanakuma
Tel
0928011011
yyoshida@fukuoka-u.ac.jp
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
福岡大学医学部 消化器外科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2012 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
