UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer
Title of the study (Brief title)	Feasibility study of S-1 and weekly cisplatin in patients recieved R0 resection gastric cancer.
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the feasibility and safety of adjuvant treatment with a combination of S-1 plus weekly CDDP in patients with gastric cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Treatment compliance with proportion of patients receiving 4 courses of Adjuvant treatment according to protocol
Key secondary outcomes	Adverse Event, Overall survival, Disease-free survival, and Relapse-free survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest. At the 2 - 4 course, S-1 plus CDDP adjuvant chemotherapy is conducted. After 5 course, S-1 is conducted for 6 weeks until 1 year after surgery.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Histologically proved adenocarcinoma of stmach 2) >= D2 lymphnode dissection, curability A(R0) 3) Stage IIB/III/IIIB/IIIC (Japanese classification) 4) Age between 20 and 75 5) No prior chemotherapy or radiotherapy 6) Able to started of treatment between 8 weeks after surgery 7) ECOG performance status 0-1 8) With ability of oral intake 9) Patients have enough organ function for study treatment Hemoglobin >9.0g.dl WBC 3,500/mm3< <12,000/mm3 Neutrophil > 2,000/mm3 Platelets >100,000/mm3 Total bilirubin <1.5mg/dl AST and ALT < 100IU Ccr > 60ml/min 10) Written informed consent
Key exclusion criteria	1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2) administration contraindication to S-1 and CDDP 3) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 4) with active infection 5) with drug hypersensitivity 6) other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 7) with water solubility diarrhea 8) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 9) men with willing to get pregnant 10)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroyuki Konno
Organization	Hamamatsu University School of Medicine
Division name	Second Department of Surgery
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan
TEL	053-435-2279
Email	otam@hama-med.ac.jp

Public contact
Name of contact person	Manabu Otha
Organization	Hamamatsu University School of Medicine
Division name	Hamamatsu University School of Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan
TEL	053-435-2279
Homepage URL
Email	otam@hama-med.ac.jp

Sponsor
Institute	Hamamatsu Organization for Oncology Research and Education : HORE
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hamamatsu Organization for Oncology Research and Education : HORE
Organization
Division
Category of Funding Organization	Other
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	浜松医科大学（静岡県） 県西部浜松医療センター（静岡県） 磐田市立総合病院（静岡県）

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 30 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 05 Month 13 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006619