UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000661
Receipt No. R000000796
Scientific Title A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer
Date of disclosure of the study information 2007/04/05
Last modified on 2017/02/12

* 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 A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer
Acronym OGSG0404
Scientific Title A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer
Scientific Title:Acronym OGSG0404
Region
Japan

Condition
Condition advanced and/or recurrent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effectiveness and feasibility of TS-1 to the senior patients older than 75 years old are detected through a phase II study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Aanti-cancer effects (Response Rate, Response Period)
Key secondary outcomes Feasibility (Incidence of Adverse Events), Overall Survival, Progression Free Survival, Time to Treatment Failure, Relationship to the score of MMSE

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose by Ccr:
Ccr 80ml/min<= body surface 1.5m2<=:120mg/body/day, 1.25-1.5:100mg/body/day, 1.25>:80mg/Body/day
Ccr 50mg/min<= and 80mg/min>:1 dose down(1.5m2<=:100mg/body/day, 1.25-1.5: 80mg/body/day, 1.25>: 50mg/body/day)
Ccr 30mg/min<= and 50mg/min>:2 dose down(1.5m2<=: 80mg/body/day, 1.25-1.5: 50mg/body/day, 1.25>: 40mg/body/day)
TS-1 is administered 4 weeks continuously and 2 weeks off, sebsequently
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. histologically proven gastric cancer
2. with measurable lesion on CT
3. aged over 75years old
4. PS:0-2
5. patients who can eat orally
6. Labo Data
1) WBC 4,000<= and <12,000 mm3
2) Neutrocyte 2,000mm3<=
3) Platelet 100,000mm3<=
4) Hemoglobin 8.0 g/dl<=
5) AST,ALT <=100 IU/L
or <=150 IU/L for patients with liver metastasis
6) Total Bil.: within normal range in each institute
7) serum creatinin <=1.2 mg/dl
8) expected creatinin clearance: >=30 mg/min by Cockcroft-Gault
7. without prior treatment(radiation therapy, chemotherapy or hormon therapy).
with postoperative adjuvant chemotherapy which has completed 6 months before
8. patients expected more than 3 months survival
9. with written informed consent
10. expected sufficient compliance
11. with MMSE data before treatment
Key exclusion criteria 1. with active double cancer
2. with severe other diseases(intestinal paralysis, ileus, intersitial pneumonitis or
plumonary fibrosis, uncontrolled DM, cardiac failure, renal dysfunction, liver
dysfunction, respiratory dysfunction)
3. severe ascites and/or pulmonary fluid
4. metastasis on central nerve system with symptom
5. fresh bleeding on digestive tract
6. with severe ischemic cardiac disease which needs treatment
7. hypersensitive response to TS-1
8. with severe bone marrow supplession, renal dysfunction or liver dysfunction
9. under administration of flucytosine
10. patients who underwent postoperative adjuvant chemotherapy of TS-1
11. doctor's exclusion due to some reason
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imamura Hiroshi
Organization Toyonaka City Hospital
Division name Department of Surger
Zip code
Address 4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL 06-6843-0101
Email imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Imamura Hiroshi
Organization Toyonaka City Hospital
Division name Department of Surger
Zip code
Address 4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL 06-6843-0101
Homepage URL
Email imamurahiroshisakai@yahoo.co.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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
2007 Year 04 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.tandfonline.com/doi/abs/10.1179/1973947813Y.0000000116?journalCode=yjoc20
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 Completed
Date of protocol fixation
2004 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2010 Year 06 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
2007 Year 03 Month 29 Day
Last modified on
2017 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.