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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005424
Receipt No. 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 2019/10/18

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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
Email 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
Email iwasaki-yuri@hitoyoshi.jcho.go.jp

Sponsor
Institute Japan Community Healthcare Organization(JCHO)Hitoyoshi Medical Center-Department of Surgery
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 Japan Community Healthcare Organization Hitoyoshi Medical Center Institutional review board
Address 35oikami-machi,hitoyoshi,kumamoto868-8555,Japan
Tel 0966-22-2191
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 53
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 No longer recruiting
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
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
2019 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.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


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