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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036157
Receipt No. 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

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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
Email 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
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 Kyoto Katsura Hospital
Address Yamadahirao-cho, Nishikyo-ku, Kyoto, 615-8256, Japan
Tel 075-391-5811
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041172

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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