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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023527
Receipt No. R000027098
Scientific Title A exploratory phase II study of SOX followed by interval S-1 alone therapy for advanced gastric cancer: Stop and Go study
Date of disclosure of the study information 2016/12/01
Last modified on 2019/08/19

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Basic information
Public title A exploratory phase II study of SOX followed by interval S-1 alone therapy for advanced gastric cancer: Stop and Go study
Acronym SOX followed by interval S-1 alone therapy for advanced gastric cancer
Scientific Title A exploratory phase II study of SOX followed by interval S-1 alone therapy for advanced gastric cancer: Stop and Go study
Scientific Title:Acronym SOX followed by interval S-1 alone therapy for advanced gastric cancer
Region
Japan

Condition
Condition advanced gastric cancer
Classification by specialty
Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the feasibility of SOX followed by interval S-1 therapy for unresectable advanced gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression-free survival
Key secondary outcomes response rate, overall survival, toxicity

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
Interventions/Control_1 L-OHP,130mg/m2 DIV on day1
S-1,80 to 120mg/m2 PO on day1 to 14
1 cycle,3 weeks
Continue for 4 cycles
After 4 cycles,S-1 alone is continued 4 cycles
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. Histologically proven adenocarcinoma
2. Unresectable advanced gastric cancer
3. No massive ascites
4. No metastasis to the central nervous system
5. Patients with and without measurable lesion
6. Possible to oral intake
7. PS: 0 or 1
8. HER2 negative
9. No previous chemothearpy
a. more than 24 weeks after S-1 administration completed
b. no more than 1040mg/m2 of oxalipalatin
10. no lethal disfunction of the major organs
11. Who gave informed consent
Key exclusion criteria 1. Drug allergy
2. Peripheral neurodisturvance
3. GI tract bleeding
4. Continuation of phenitoin, warfain
5. Uncontrollable infection
6. Interstitial pneumonia
7. Other cancers
8. DPD deficiency
9. Family planning
10. Inappropriate patients
Target sample size 65

Research contact person
Name of lead principal investigator
1st name Chikara
Middle name
Last name Kunisaki
Organization Medical Center, Yokohama City University
Division name Department of Surgery, Gastroenterological Center
Zip code 232-0024
Address 4-57, Urafune-cho, Minami-ku, Yokohama
TEL 045-261-5656
Email s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Chikara
Middle name
Last name Kunisaki
Organization Medical Center, Yokohama City University
Division name Department of Surgery, Gastroenterological Center
Zip code 232-0024
Address 4-57, Urafune-cho, Minami-ku, Yokohama
TEL 045-261-5656
Homepage URL
Email s0714@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Surgery, Gastroenterological Center, Medical Center, Yokohama City University
Institute
Department

Funding Source
Organization Medical Center, Yokohama City University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Y-NEXT
Address 1-1-1, Fukuura, Kanazawa-ku, Yokohama
Tel 045-370-7943
Email ycu_crb@yokohama-cu.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
2016 Year 12 Month 01 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 24
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 01 Month 22 Day
Date of IRB
2015 Year 05 Month 27 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 07 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027098

Research Plan
Registered date File name
2017/08/13 臨床研究実施計画書 ver1.2.docx

Research case data specifications
Registered date File name
2017/08/13 臨床研究実施計画書 ver1.2.docx

Research case data
Registered date File name


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