UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032182 |
|---|---|
| Receipt number | R000036615 |
| Scientific Title | Prospective Observational Study of Efficacy and Safety in Chemotherapy After Refractory or Intolerant to Nivolumab Therapy for Unresectable Advanced or Recurrent Gastric Cancer |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2023/12/01 15:41:49 |
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Basic information
Public title
Prospective Observational Study of Efficacy and Safety in Chemotherapy After Refractory or Intolerant to Nivolumab Therapy for Unresectable Advanced or Recurrent Gastric Cancer
Acronym
REVIVE study (CSPOR GC-01)
Scientific Title
Prospective Observational Study of Efficacy and Safety in Chemotherapy After Refractory or Intolerant to Nivolumab Therapy for Unresectable Advanced or Recurrent Gastric Cancer
Scientific Title:Acronym
REVIVE study (CSPOR GC-01)
Region
| Japan |
Condition
Condition
Advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of chemotherapy in patients with advanced or recurrent gastric cancer who received nivolumab therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of chemotherapy after nivolumab therapy
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Select patients who meet the following eligibility criteria A, obtain written informed consent, and then register primarily. After primary registration, select patients who meet eligibility criterion B and formally register.
Eligibility Criteria A (at primary registration)
1)This is a case of unresectable or recurrent gastric cancer histologically confirmed to be the primary adenocarcinoma of the stomach. Carcinoma of the esophagogastric junction, in which the tumor center is within 2 cm from the gastroesophageal junction, is tolerated.
2)Patients being treated with nivolumab
3)Prior treatment for advanced or recurrent gastric cancer includes all of the following.
(a)Refractory/intolerant to combination therapy with fluorinated pyrimidine anticancer drugs (e.g., 5-FU, S-1, capecitabine, UFT) and platinum anticancer drugs (cisplatin or oxaliplatin).
(b)Resistance or intolerance to taxanes.
(c)The use of trastuzumab or ramucirumab is no object.
4)Patients who have been fully informed of this study and have given written informed consent
Eligibility Criteria B (at formal registration)
1)Patients refractory or intolerant to nivolumab therapy
2)Patients who are scheduled to receive cytotoxic chemotherapy, such as irinotecan therapy, for treatment of refractory or intolerant to nivolumab.
*Acceptable regimens include: irinotecan monotherapy (with or without ramucirumab or trastuzumab) or oxaliplatin combination regimens (with SOX, XELOX, or FOLFOX) for patients refractory or intolerant to cisplatin
3)Cases with Performance Status (PS) of 0-2 in ECOG
4)Patients with evaluable lesions according to RECIST(ver1.1)
Key exclusion criteria
1)Patients for whom the attending physician considered enrollment in the study inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center Central Hospital
Division name
Department of Pharmacotherapy
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Japan
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Yukiya |
| Middle name | |
| Last name | Narita |
Organization
Aichi Cancer Center Central Hospital
Division name
Department of Pharmacotherapy
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Japan
TEL
052-762-6111
Homepage URL
yukiya.narita@aichi-cc.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb Co., Ltd.
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
Aichi cancer senter,Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Japan
Tel
052-762-6111
no@mail
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
愛知県がんセンター中央病院
手稲渓仁会病院
市立札幌病院
北海道大学病院
斗南病院
三沢市立三沢病院
大崎市民病院
日本赤十字社 石巻赤十字病院
筑波大学附属病院、埼玉県立がんセンター
東京女子医科大学附属八千代医療センター
国家公務員共済組合連合会 虎の門病院
国立研究開発法人 国立がん研究センター中央病院
聖マリアンナ医科大学病院
神奈川県立病院機構 神奈川県立がんセンター
金沢大学附属病院
石川県立中央病院
社会医療法人財団慈泉会 相澤病院
岐阜大学医学部附属病院
静岡県立静岡がんセンター
独立行政法人国立病院機構 名古屋医療センター
名古屋市立大学病院
藤田保健衛生大学病院
独立行政法人国立病院機構 京都医療センター
地方独立行政法人 市立東大阪医療センター
大阪医科大学附属病院
独立行政法人国立病院機構 大阪医療センター
大阪急性期・総合医療センター
大阪赤十字病院
近畿大学医学部附属病院
地方独立行政法人大阪府立病院機構 大阪国際がんセンター
地方独立行政法人神戸市民病院機構 神戸市立医療センター中央市民病院
兵庫医科大学病院
兵庫県立がんセンター
姫路赤十字病院
川崎医科大学附属病院
県立広島病院
香川大学医学部附属病院
独立行政法人国立病院機構 四国がんセンター
JCHO九州病院
九州大学大学院
日本赤十字社長崎原爆病院
熊本大学医学部附属病院
大分大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 10 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036615
