UMIN-CTR Clinical Trial

Basic information
Public title	A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer
Acronym	Adjuvant S-1+CDDP for stage III gastric cancer
Scientific Title	A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer
Scientific Title:Acronym	Adjuvant S-1+CDDP for stage III gastric cancer
Region	Japan

Condition
Condition	Stage III (the 14th edition of staging system of Japanese Classification of Gastric Carcinoma) gastric cancer based on pathological findings after curative resection.
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study will evaluate the feasibility of TS-1 and cisplatin for patients of stage III gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The proportion of accomplishing three cycles S-1+CDDP therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 and cisplatin
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with histologically proved adenocarcinoma of advanced gastric cancer and esophagogastric junction. 2) Patients after curative resection of gastric cancer, and was diagnosed stage III (14th staging system of Japanese Gastric Cancer Association). 3) Age: 20-75. 4) ECOG performance status 0-1. 5) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 8.0 g/dL, platelet count >= 100,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 1.5 mg/dL), kidney function (serum creatinine <=1.5 mg/dL). 6) Patients who can intake orally. 7) Written informed consent obtained from patients.
Key exclusion criteria	1) Patients who received surgery within 2 weeks before enrollment. 2) Patients with uncontrable diabetis. 3) Patients who has past history of myocardial infarction within 6 months before enrollment or who has unstable angina. 4) Patients who receive anti-arrhythmia drug (except warfarin for atrial fibrillation). 5) Patients with liver chirrosis. 6) Patients with severe renal failure. 7) Patients with ileus or subileus. 8) Patients who receive continuous corticosteroid administration. 9) Patients with active infections. 10) Patients with uncontrollable ascites, pleural effusion or pericardial effusion. 11) Patients with a history of serious drug allergy. 12) Patients with grade 2-4 diarrhea based on CTCAE ver 4. 13) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. Pregnant or lactating female. 14) Patients with grade 2-4 neuropathy based on CTCAE ver 4. 15) Patients who recieved transfusion within 2 weeks before enrollment, or has active bleeding. 16) Pregnant or lactating female. 17) Other patients evaluated to be inadequate to participate in this study by investigators.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Koichi Middle name Last name Suyama
Organization	Toranomon Hospital
Division name	Department of Medical Oncology
Zip code	105-8470
Address	2-2-2 Toranomon, Minato-ku, Tokyo,JAPAN
TEL	0335881111
Email	kou_susan@yahoo.co.jp

Public contact
1st name of contact person	1st name Koichi Middle name Last name Suyama
Organization	Toranomon Hospital
Division name	Department of Medical Oncology
Zip code	105/8470
Address	2-2-2 Toranomon, Minato-ku, Tokyo,JAPAN
TEL	0335881111
Homepage URL
Email	kou_susan@yahoo.co.jp

Sponsor
Institute	Department of Medical Oncology, Toranomon Hospitalnasoi
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toranomon Hospital IRB
Address	2-2-2, Toranomon,Minato-ku, Tokyo, Japan
Tel	0335881111
Email	chiken-jim@toranomon.gr.jp

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	2014 Year 03 Month 24 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	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date	2014 Year 03 Month 24 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	2014 Year 03 Month 21 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015737