UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036157 |
|---|---|
| Receipt number | R000041172 |
| Scientific Title | A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2019/03/11 18:02:19 |
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Basic information
Public title
Study on safety and efficacy of mFOLFOX6 after exposure to an immune checkpoint inhibitor in advanced gastric cancer
Acronym
Study on safety and efficacy of mFOLFOX6 after exposure to an immune checkpoint inhibitor in advanced gastric cancer
Scientific Title
A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer
Scientific Title:Acronym
A phase II study of mFOLFOX6 after exposure to Nivolumab in advanced 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 mFOLFOX6 after exposure to Nivolumab in advanced gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Incidence of adverse events
Disease control rate
Progression-free survival
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 |
Interventions/Control_1
The treatment consisted in the administration of 85 mg/m2 oxaliplatin and 200 mg/m2 LV by a 2-h intravenous infusion, followed by the administration of 400 mg/m2 bolus 5-FU and 2400 mg/m2 5-FU by a 46-h continuous infusion. The treatment was repeated every 2 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric
adenocarcinoma
2) Age above 20 years old
3) ECOG performance status of 0 or 1
4) 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
5) Written informed consent from patient
6)Patients undergoing exposure to immune checkpoint inhibitors in advanced gastric cancer
Key exclusion criteria
1) Severe complications
2) With active infection
3) Past history of severe hypersensitivity to drugs
4) Pregnant women, or women with the
possibility of the pregnancy, Men who want let to pregnancy
5) Patients judged inappropriate for the study by the physicians
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Manaka |
Organization
Kyoto Katsura Hospital
Division name
Department of Surgery, Gastro-Intestinal Center
Zip code
615-8256
Address
17 Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL
075-391-5811
d_manaka@katsura.com
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Konishi |
Organization
Kyoto Katsura Hospital
Division name
Department of Surgery, Gastro-Intestinal Center
Zip code
615-8256
Address
Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
TEL
075-391-5811
Homepage URL
sayurik0713@gmail.com
Sponsor or person
Institute
Kyoto Katsura Hospital
Institute
Department
Personal name
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
Kyoto Katsura Hospital
Address
Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
Tel
075-391-5811
chiken@katsura.com
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
| 2019 | Year | 03 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041172
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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