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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013185
Receipt No. R000015242
Scientific Title Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer
Date of disclosure of the study information 2014/02/18
Last modified on 2016/06/30

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Basic information
Public title Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer
Acronym Study of Alternate-day administrations of TS-1 for resected Colorectal Cancer
Scientific Title Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer
Scientific Title:Acronym Study of Alternate-day administrations of TS-1 for resected Colorectal Cancer
Region
Japan

Condition
Condition Stage III colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of daily administrations and alternate-day administrations of TS-1 in curatively resected Stage III colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Treatment Completion Rate
Key secondary outcomes 3-year Disease-Free Survival
Overall Survival
Compliance
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Standard Arm(Daily administrations)
TS-1 is administered orally for 28 days, followed by 14 days rest. Administrations are conducted for 24 weeks from the date of the start of the therapy. After the treatment, patients are simply observed without any more therapy, unless any recurrent lesions or any other cancer lesions are observed in them.
Interventions/Control_2 Testing Arm(Alternate-day administrations)
TS-1 is administered orally at Monday, Wednesday, Friday and Sunday.
Administrations are conducted for 28 weeks from the date of the start of the therapy. After the treatment, patients are simply observed without any more therapy, unless any recurrent lesions or any other cancer lesions are observed in them.
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)Histologically proven, Stage III, (Japanese Classification of Colorectal cancer 8th Edition) primary Colon cancer or RS.
2)Curability A
3)Age between 20 and 80 years.
4)Performance status(ECOG) of 0-1.
5)No prior therapy expect the operation.
6)Capability of oral intake
7)Patients who have satisfied the clinical test values within 14 days before the registration.
8)Patient with starting the treatment within 8 weeks after operation.
9)Written informed consent.
Key exclusion criteria 1)Active double cancer
2)Synchronous or metachronous malignancy other than carcinoma in situ.
3)Severe postoperative complications.
4)Severe complication.
5)Severe diarrhea.
6)Severe infectious disease.
7)Medical history of severe anaphylaxis or allergia to any drug.
8)Undergoing treatment with fluorocytosine.
9)Hepatitis B virus infection, hepatitis C virus infection.
10)Women who are pregnant or breast-feeding, or Women who may become pregnant and fertile men.
11)Severe mental disorder.
12)Patients judged inappropriate for the study by their physicians.
Target sample size 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chu Matsuda
Organization Osaka General Medical Center
Division name Surgery
Zip code
Address 3-1-56,Bandaihigashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Email chu0219pinefield@gh.opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taishi Hata
Organization Osaka University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3251
Homepage URL
Email thata@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Clinical Study Group of Osaka (CSGO), Colorectal Cancer Treatment Group
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 18 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
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 07 Month 24 Day
Date of closure to data entry
2015 Year 07 Month 24 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 18 Day
Last modified on
2016 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/01/09 大腸癌術後補助化学療法におけるTS-1の投与方法に関するrandomized Phase II trial.zip


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