UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of TS-1 and oxaliplatin for Stage III gastric cancer in adjuvant setting
Title of the study (Brief title)	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	Hiroaki Tanaka
Organization	Osaka City University Graduate School of Medicine
Division name	Departiment of Surgical Oncology,
Address	1-4-3, Asahimachi, Abenoku, Osaka
TEL	06-6645-3838
Email	hiroakitan@med.osaka-cu.ac.jp

Public contact
Name of contact person	Hiroaki Tanaka
Organization	Osaka City University Graduate School of Medicine
Division name	Departiment of Surgical Oncology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 06 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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