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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009325
Receipt No. R000010827
Scientific Title Switch maintenance using UFT/LV therapy after Oxaliplatin based adjuvant chemotherapy for StageIII colorectal cancer
Date of disclosure of the study information 2012/11/13
Last modified on 2012/11/13

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Basic information
Public title Switch maintenance using UFT/LV therapy after Oxaliplatin based adjuvant chemotherapy for StageIII colorectal cancer
Acronym FUTURE1202(SWIM III)
Scientific Title Switch maintenance using UFT/LV therapy after Oxaliplatin based adjuvant chemotherapy for StageIII colorectal cancer
Scientific Title:Acronym FUTURE1202(SWIM III)
Region
Japan

Condition
Condition StageIII 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 maitenance using UFT plus LV after Oxaliplatin based adjuvant chemotherapy for stageIII cololectal cancer with curative 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 rate of treatment, Safety
Key secondary outcomes 3year disease free survival time

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(4 weeks on,1week off )
to be repeated every 5 weeks.
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
stageIII colorectal cancer.
2. Patients recieved Oxaliplatin based
chemotherapy as a prior therapy.
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
within 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
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University Faculty of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 7-45-1,Nanakuma,Johnan-ku,Fukuoka,814-0180,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University Faculty of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 7-45-1,Nanakuma,Johnan-ku,Fukuoka,814-0180,Japan
TEL
Homepage URL
Email

Sponsor
Institute Fukuoka Tumor Research(FUTURE)
Institute
Department

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
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 福岡大学医学部消化器外科学

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 13 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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 05 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 11 Month 13 Day
Last modified on
2012 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010827

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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