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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031388
Receipt No. R000034119
Scientific Title Pilot study of neoadjuvant chemotherapy with S-1 and oxaliplatin clinical Stage III gastric cancer
Date of disclosure of the study information 2018/02/20
Last modified on 2018/02/20

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Basic information
Public title Pilot study of neoadjuvant chemotherapy with S-1 and oxaliplatin clinical Stage III gastric cancer
Acronym Pilot study of neoadjuvant chemotherapy with S-1/oxaliplatin in clinical Stage III gastric cancer
Scientific Title Pilot study of neoadjuvant chemotherapy with S-1 and oxaliplatin clinical Stage III gastric cancer
Scientific Title:Acronym Pilot study of neoadjuvant chemotherapy with S-1/oxaliplatin in clinical Stage III gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of S-1 and oxaliplatin as neoadjuvant chemotherapy for the clinical Stage III gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Completion rate of neoadjuvant chemotherapy
Completion rate of adjuvant chemotherapy
Pathological response rate
Incidence of adverse events of neoadjuvant chemotherapy
Incidence of postoperative complications
R0 resection rate
Progression-free survival
Overall survival
Completion rate of laparoscopic surgery

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 S-1:80-120mg/body/day,PO,day1-14,
Oxaliplatin:130 mg/m2, IV day1, every 21 days for 2 cycles followed by D2 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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric
adenocarcinoma
2) Clinical Stage III gastric cancer
3) Age above 20 years old
4) ECOG performance status of 0 or 1
5) No previous chemotherapy,radiation
therapy or surgery for gastric cancer
6) Adequate organ function
1. WBC:>=3,000/mm3,<12,000/mm3
2. Neutrophil:>=1,500/mm3
3. Platelet:>=100,000/mm3
4. Hemoglobin:>=9.0g/dL
5. AST(GOT)/ALT(GPT):<=100 IU/L
6. Total bilirubin:<=2.0mg/dL
7. Serum creatinine:<=1.2mg
8. Creatinine clearance:>=60 mL/min
7) Possible oral intake
8) Written informed consent from patient

Key exclusion criteria 1) With active double or multiple cancers
2) Severe complications
3) With active infection
4) Past history of severe hypersensitivity to drugs
5) Under treatment with flucytosine
6) Under treatment with warfarin
7) Pregnant women, or women with the
possibility of the pregnancy, Men who want let to pregnancy
8) Patients judged inappropriate for the study by the physicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayuri Konishi
Organization Kyoto Katsura Hospital
Division name Department of Surgery, Gastro-Intestinal Center
Zip code
Address 17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL 075-391-5811
Email d_manaka@katsura.com

Public contact
Name of contact person
1st name
Middle name
Last name Sayuri Konishi
Organization Kyoto Katsura Hospital
Division name Department of Surgery, Gastro-Intestinal Center
Zip code
Address Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL 075-391-5811
Homepage URL
Email sayurik0713@gmail.com

Sponsor
Institute Kyoto Katsura Hospital
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
Address
Tel
Email

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
2018 Year 02 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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 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
2018 Year 02 Month 20 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034119

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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