UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049928 |
|---|---|
| Receipt number | R000056870 |
| Scientific Title | A prospective observational study of nivolumab plus chemotherapy for advanced gastric cancer using CyberOncology (WJOG15922G) |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2024/11/12 11:44:27 |
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Basic information
Public title
A prospective observational study of nivolumab plus chemotherapy for advanced gastric cancer using CyberOncology (WJOG15922G)
Acronym
PROCEED
Scientific Title
A prospective observational study of nivolumab plus chemotherapy for advanced gastric cancer using CyberOncology (WJOG15922G)
Scientific Title:Acronym
PROCEED
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent gastric or esophagogastric junction cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the efficacy and safety of nivolumab plus chemotherapy for HER2-negative, unresectable advanced or recurrent gastric cancer in clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall Survival, Time to Treatment Failure, Overall Response Rate, Duration of Response, Disease Control Rate, Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed unresectable or recurrent gastric or esophago-gastric junction adenocarcinoma
2) HER2 negative
3) Planned to receive nivolumab plus chemotherapy
4) No prior systemic anticancer therapy for advanced or metastatic disease
5) Eastern Cooperative Oncology Group (ECOG)Performance status of 0-2
6) Life expectancy of at least 3 months
7) Evaluable lesions based on CT or MRI within 30 days prior to registration
8) Available tumor specimens for biomarker analysis
9) Without severe organ dysfunction confirmed by laboratory test within 30 days prior to registration
Key exclusion criteria
1) Concomitant active malignancies within 3 years prior to registration
2) Active autoimmune disease
3) Requiring systemic corticosteroid or immunosuppressant within 14 days prior to registration
4) Active infection under treatment
5) Pregnant or lactating female
6) Uncontrolled psychiatry disease
7) History of serious allergic reactions
8) Judged inappropriate by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Okamoto |
Organization
Hiroshima University Hospital
Division name
Cancer Treatment Cente
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 Japan
TEL
082-257-5981
wokamoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
Kasumi 1-2-3,Minami Ku, Hiroshima City, Hiroshima prefecture, Japan
Tel
082-257-5907
iryo-seisaku@office.hiroshima-u.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
| 2022 | Year | 12 | Month | 28 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 10 | Month | 31 | Day |
Other
Other related information
To prospectively evaluate the efficacy and safety of nivolumab plus chemotherapy for HER2-negative, unresectable advanced or recurrent gastric cancer in clinical practice
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056870
