UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014331 |
|---|---|
| Receipt number | 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 10:11:01 |
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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
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
hkawakubo@z3.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016683
