UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023560 |
|---|---|
| Receipt number | R000027128 |
| Scientific Title | A feasibility study of TS-1 and oxaliplatin for Stage III gastric cancer in adjuvant setting |
| Date of disclosure of the study information | 2017/08/04 |
| Last modified on | 2016/08/09 13:00:46 |
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Basic information
Public title
A feasibility study of TS-1 and oxaliplatin for Stage III gastric cancer in adjuvant setting
Acronym
A feasibility study of TS-1 and oxaliplatin for gastric cancer
Scientific Title
A feasibility study of TS-1 and oxaliplatin for Stage III gastric cancer in adjuvant setting
Scientific Title:Acronym
A feasibility study of TS-1 and oxaliplatin for gastric cancer
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility of TS-1 and oxaliplatin for gastric cancer in adjuvant setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of the patients who completed the treatment
Key secondary outcomes
3 year Relapse-free survival
3 year overall survival
Rate of adverse event
Rate of peripheral sensory neuropathy
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
1st course: TS-1 80mg/m2 Day1-14 q3w
2nd-8th course: Oxaliplatin 100mg/m2 Day1 TS-1 80mg/m2 Day1-14 q3w
9th course until end: TS-1 80mg/m2 Day1-28 q6w
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
1. Pathologically confirmed common type of gastric cancer with Stage IIIA, IIIB and IIIC
2. Completely resected gastric cancer with D2 lymphadenectomy
3. Without distant metastasis including positive peritoneal cytology
4. ECOG performance status are 0 or 1.
5. Within 6 weeks after surgical treatment
6. Without preoperative therapy (including chemotherapy or radiotherapy)
7. With adequate major organ functions within 14 days before trial entry, as defined below:
1) White blood cell count >= 4,000/mm3 or <=12,000mm3
2) Neutrophil count >= 1,500/mm3
3) Hemoglobin >= 9.0 g/dL
4) Platelet count >= 100,000/mm3
5) AST <= 100IU/L
6) ALT <= 100IU/L
7) Total Bilirubin<= 1.5 mg/dL
8) Serum Creatinine <= 1.2 mg/dL
9) Creatinine clearance >= 50ml/hr
10. Written informed consent must be taken by patients
Key exclusion criteria
1. With synchronous or metachronous (within 5 year before entry) double cancer, except for situ carcinoma
2. Severe surgical complication
3. Severe complication; such as uncontrollable diabetes mellitus or hypertension
4.With Peripheral sensory neuropathy
5. Active infectious disease
6. Positive for HBs antigen or HCV antibody
7. Continuous administration of steroids
8. Severe diarrhea
9. With drug allergy for both of iodine and gadolinium
10. Continuous flucytosine, phenytoin, and warfarin potassium treatment
11. Women during pregnancy, possible pregnancy, or breast-feeding and men with making pregnant
12. Cases judged to be inappropriate by attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Departiment of Surgical Oncology,
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3838
hiroakitan@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Departiment of Surgical Oncology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
06-6645-3838
Homepage URL
hiroakitan@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgical Oncology, Osaka City University Graduate School of Medicine
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
| 2017 | Year | 08 | Month | 04 | 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
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027128
