UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with Stage III gastric cancer patients
Title of the study (Brief title)	Feasibility Study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with StageIII gastric cancer patients
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate the tolerability of S-1/oxaliplatin combination adjuvant chemotherapy for Stage III gastric cancer patients after D2 gastrectomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment completion rate of up to protocol treatment 5 courses.
Key secondary outcomes	Adverse events occurrence rate

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	cycle S-1:80-120mg/day. 2-4 cycle S-1:80-120mg/day. S-1 was given orally daily 2 weeks of 3week-cycle.Oxaliplatin 100mg/m2 was administered first cycle of 3 week-cycle as same schedule of S-1.
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) Histological proven gastric cancer 2) Surgical operated by D2 lymphadenectomy and curability A 3) Clinical Stage IIIA,IIIB,IIIC(T2N3, T3N2-3, T4aN1-3, T4bN0-3) according to Japanese Classification of Gastric Cancer 14th edition 4) Age 20-80 years 5) No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery 6) Capable of protocol therapy within 56 days after gastrectomy. 7) PS(ECOG) 0 or 1 8) Capable oral food uptake. 9) Clear to the criteria as below within 14days after registration. Hemoglobin:> 9.0 g/dL Leukocyte: >3,000 /mm3 <12,000 /mm3 Neutrophil: >1,500 /mm3 Blood platelet count: >100,000/mm3 Total bilirubin: <1.5mg/dl AST(GOT) ALT(GPT): <100 IU/L Creatinine clearance: >60 mL/min 10) Capable to have given written informed consent to participate in this study
Key exclusion criteria	1) Active synchronous metachronous malignancy with longer than 5year interval period without below written cases Carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer. 2) Contraindication of S-1 and Oxaliplatin 3) Regular use of flucytosine, phenytoin or warfarin potassium 4) Active infection with over 38 degree fever 5) History of serious drug hypersensitivity 6) Any other serious illness or medical conditions including interstitial paresis, intestinal obstruction, pneumonitis, pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure. 7) HIV positive or active hepatitis 8) Severe diarrhea (over 4 times/day or watery diarrhea) 9) Pregnancy or lactation 10) Male intension that get with child 11) Patients who are recognized as inadequate patients by doctor with responsibility in this study.
Target sample size	25

Research contact person
Name of lead principal investigator	Kinji Kamiya
Organization	Hamamatsu University Hospital
Division name	2nd department of surgery
Address	1-20-1 Handayama Higashi-ku Hamamatsu City Shizuoka prif. Japan 431-3192
TEL	053-435-2279
Email	kamikin@hama-med.ac.jp

Public contact
Name of contact person	Kinji Kamiya
Organization	Hamamatsu University Hospital
Division name	2nd department of surgery
Address	1-20-1 Handayama Higashi-ku Hamamatsu City Shizuoka prif. Japan 431-3192
TEL	053-435-2279
Homepage URL
Email	kamikin@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2016 Year 07 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 23 Day
Anticipated trial start date	2016 Year 09 Month 01 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 07 Month 20 Day
Last modified on	2017 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026806