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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014331
Receipt No. R000016683
Scientific Title Phase II study of neoadjuvant chemoradiotherapy of s-1 and cisplatin for advanced gastric cancer with lymph node metastases (Neo-KOGC04 study)
Date of disclosure of the study information 2014/06/20
Last modified on 2019/12/23

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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