UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023527 |
|---|---|
| Receipt number | 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 17:36:59 |
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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
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
s0714@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Surgery, Gastroenterological Center, Medical Center, Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
