UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001148 |
|---|---|
| Receipt number | R000001394 |
| Scientific Title | Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer. |
| Date of disclosure of the study information | 2008/05/07 |
| Last modified on | 2010/01/29 19:56:33 |
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Basic information
Public title
Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.
Acronym
Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.
Scientific Title
Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.
Scientific Title:Acronym
Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility of adjuvant UFT after withdrawal of adjuvant TS-1 (Regimen of ACTS-GC) with adverse effects in patients with curatively resected gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Safety of UFT
Relapse-Free Survival
Overall Survival
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
UFT:300-600 mg/body/day Day 1-5
One course takes 7 days.
In total of one year administration of UFT and TS-1
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
Histological proven gastric carcinoma
D>=2 lymph node dissection and curability A or B
stage II/III(except for T1)
Age 20-80 years
Despite adjust dose and regimen, duration of TS-1 is less than 6 months caused by adverse effects.
within 1-7 weeks after dropping TS-1
Adequate cardiac, hepatic, renal,
respiratory, and bone marrow functions.
Written informed consent.
Key exclusion criteria
administration contraindication of UFT
Severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
Severe watery diarrhea.
HIV+
Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastrointestinal Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL
078-382-5925
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastrointestinal Surgery
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL
078-382-5925
Homepage URL
Sponsor or person
Institute
Division of Gastrointestinal Surgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2008 | Year | 05 | Month | 07 | 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
Suspended
Date of protocol fixation
| 2008 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | 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
| 2008 | Year | 05 | Month | 07 | Day |
Last modified on
| 2010 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001394
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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