UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of neoadjuvant chemoradiotherapy of s-1 and cisplatin for advanced gastric cancer with lymph node metastases (Neo-KOGC04 study)
Acronym	Phase II study of neoadjuvant chemoradiotherapyfor advanced gastric cancer (KOGC04 study)
Scientific Title	Phase II study of neoadjuvant chemoradiotherapy of s-1 and cisplatin for advanced gastric cancer with lymph node metastases (Neo-KOGC04 study)
Scientific Title:Acronym	Phase II study of neoadjuvant chemoradiotherapyfor advanced gastric cancer (KOGC04 study)
Region	Japan

Condition
Condition	Advanced Gastric Cancer
Classification by specialty	Hematology and clinical oncology Surgery in general Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and safety of neoasjuvant chemoradiotherapy of S-1 and cisplatin for advanced gastric cancer with multiple lymph node metastases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate of neoadjuvant chemoradiotherapy
Key secondary outcomes	Pathological response rate, compliance of neoadjuvant therapy, compliance of adjuvant therapy, curable resection rate, rate of adverse event, 3-year Relapse-free survival, 3-year Overall survival

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 Maneuver
Interventions/Control_1	1st course S-1: 80mg/m2 Day 1-14 Cisplatin: 20mg/m2 Day 1, 15 Radiation: 40Gy/20Fr (Primary tumor and regional lymph node) 2nd course S-1: 80mg/m2 Day 1-28 Cisplatin: 20mg/m2 Day 1, 15, 29 Surgery should be performed after the completion of neoadjuvant chemoradiotherapy within 8 weeks.
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) adenocarcinoma of the stomach 2) lymph node metastasis (evaluable by RECIST ver. 1.1) 3) The depth is either T3 or T4 4) The invasion to esophagus is within 3cm. 5) Age: From 20y.o to 75 y.o. 6) ECOG PS 0 or 1 7) No prior neither chemotherapy nor radiotherapy 8) No prior gastrectomy 9) Sufficient function of important organs 10) Possible oral intake 11) written informed consent
Key exclusion criteria	1) contraindication of either S-1 or cisplatin 2) with severe infection 3) with interstitial pneumonia or pulmonary fibrosis 4) with severe diarrhea 5) with severe complication (intestinal paralysis, ileus, diabetes, renal dysfunction, liver dysfunction) 6) with other active malignant disease 7) pregnant or nursing women or women who like be pregnant and willing to get pregnant
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hirofumi Middle name Last name Kawakubo
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Email	hkawakubo@z3.keio.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Kawakubo
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	hkawakubo@z3.keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	School of Medicine, Keio University
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	Keio University School of Medicine, Ethics Committee
Address	35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.ac.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 06 Month 20 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	Completed
Date of protocol fixation	2012 Year 11 Month 16 Day
Date of IRB	2013 Year 04 Month 22 Day
Anticipated trial start date	2013 Year 04 Month 22 Day
Last follow-up date	2018 Year 04 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 20 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016683