UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005424 |
|---|---|
| Receipt number | R000006341 |
| Scientific Title | Adjuvant chemotherapy with TS-1 administered 5-days on/ 2-days off Schedule for Gastric or Colorectal cancer. |
| Date of disclosure of the study information | 2011/04/12 |
| Last modified on | 2022/04/20 11:55:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Adjuvant chemotherapy with TS-1 administered 5-days on/ 2-days off Schedule for Gastric or Colorectal cancer.
Acronym
TS-1 5-days on/ 2-days off Schedule
Scientific Title
Adjuvant chemotherapy with TS-1 administered 5-days on/ 2-days off Schedule for Gastric or Colorectal cancer.
Scientific Title:Acronym
TS-1 5-days on/ 2-days off Schedule
Region
| Japan |
Condition
Condition
Gastric or Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibilitiy, efficacy and safety of adjuvant chemothrapy with TS-1 administered 5-days on/ 2-days off Schedule to 1 year, for stageII or III; Gastric or Colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
DFS(3y), OS, safty
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
TS-1 administered 5-days on/ 2-days off Schedule
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically proven gastric or colorectal cancer.
2)Gastric cancer: p-stageIIA,IIB(excluding T1 cases and T3N0 StageIIA), IIIA, IIIB and IIIC (Japanese Classification of Gastric Carcinoma The 14th Edition).
Colorectal cancer:p-stageII, IIIA, IIIB (Japanese Classification of Colon, Rectum and Anus Carcinoma The 7th Edition, Revised Version).
Gastric and colorectal cancer(no hepatic, peritoneal or distant metastasis; no tumor cells in peritoneal fluid on cytologic analysis).
3)Gastric and colorectal cancer(D2 or more extensive lymph-node dissection with R0 surgery)
4)Age>= 20 yrs
5)Performance status 0 or 1
6)No previous treatment for cancer expect for the initial gastric or colorectal resection for the primary lesion.
7)adequate oral intake
8)Meet the following criteria for organ functions.
i)WBC>=4000/mm3 or the lower limit of the normal range.
ii)PLT>=1000000/mm3
iii)T-Bill=<1.5 mg/dl
iv)AST,ALT=< 87.5IU/L
v)CCr>= 30mL/min
9) Within 8 weeks after surgery.
10) Witten informed consent.
Key exclusion criteria
1)Active co-existing malignancy (synchronous or metachronous malignancy whose disease-free period is within 5 years).
2)Multiple cancer patients except M cancer apparent infection.
3)Severe postoperative complicatoins which do not resolve until registration.
4) Cre>=1.5 mg/dl
5)It corresponds to either the following.
i) Uncontrolled diabetes mellitus
ii) Uncontrolled hypertension
iii) Unatable angia, Cardiac infraction or the history
iv) liver cirrhosis
v) Interstitial pneumonia, fibroid lung and severe pulmonary emphysema.
6)It corresponds to either the following.
i)Pregnant females, possibly pregnant female.
ii)females wishing to become pregnant and nursing mothers.
iii)Males that are currently attempting to produce a pregnancy.
7)Severe mental disease.
8)Inadequate physical condition, as diagnosed by primary physician.
9)contraindication of TS-1.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | nobuyuki |
| Middle name | |
| Last name | ozaki |
Organization
Japan Community Healthcare Organization(JCHO)Hitoyoshi Medical Center
Division name
Department of Surgery
Zip code
8688555
Address
35oikami-machi,hitoyoshi,kumamoto868-8555,Japan
TEL
0966-22-2191
iwasaki-yuri@hitoyoshi.jcho.go.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Iwasaki |
Organization
Japan Community Healthcare Organization(JCHO)Hitoyoshi Medical Center
Division name
Clinical research center
Zip code
8688555
Address
35oikami-machi,hitoyoshi,kumamoto868-8555,Japan
TEL
0966-22-2191
Homepage URL
http://www.hitoyoshi.jcho.go.jp
iwasaki-yuri@hitoyoshi.jcho.go.jp
Sponsor or person
Institute
Japan Community Healthcare Organization(JCHO)Hitoyoshi Medical Center-Department of Surgery
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
Japan Community Healthcare Organization Hitoyoshi Medical Center Institutional review board
Address
35oikami-machi,hitoyoshi,kumamoto868-8555,Japan
Tel
0966-22-2191
iwasaki-yuri@hitoyoshi.jcho.go.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
独立行政法人地域医療機能推進機構人吉医療センター（熊本県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Cancellation can't carry it
Publication of results
Unpublished
Result
URL related to results and publications
Cancellation can't carry it
Number of participants that the trial has enrolled
53
Results
Cancellation can't carry it
Results date posted
| 2022 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cancellation can't carry it
Participant flow
Cancellation can't carry it
Adverse events
Cancellation can't carry it
Outcome measures
Cancellation can't carry it
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 12 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006341
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
