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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023560
Receipt No. 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

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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
Email 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
Email hiroakitan@med.osaka-cu.ac.jp

Sponsor
Institute Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027128

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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