UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013185 |
|---|---|
| Receipt number | 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 15:24:45 |
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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
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
thata@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Clinical Study Group of Osaka (CSGO), Colorectal Cancer Treatment Group
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015242
