UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000661 |
|---|---|
| Receipt number | R000000796 |
| Scientific Title | A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404) |
| Date of disclosure of the study information | 2007/04/05 |
| Last modified on | 2021/11/15 22:41:15 |
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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 (OGSG 0404)
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 (OGSG 0404)
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
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
imamurahiroshisakai@yahoo.co.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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
http://www.tandfonline.com/doi/abs/10.1179/1973947813Y.0000000116?journalCode=yjoc20
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
35
Results
The response rate (RR) was 14.3% and the median overall survival was 14.6 months.
Results date posted
| 2021 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2013 | Year | 02 | Month | 06 | Day |
Baseline Characteristics
Chemotherapy-naive patients aged over 75 years with adverse gastric cancer
Participant flow
Thirty-five patients were enrolled.
Adverse events
Grade 3 or more severe adverse events consisted of anemia (3%), neutropenia (3%), anorexia (3%), and fatigue (6%). There were no treatment-related deaths.
Outcome measures
response rate (RR)
overall survival (OS)
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
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000796
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