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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032182
Receipt No. 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 2018/08/06

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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
Middle name
Last name Kei Muro
Organization Aichi Cancer Center Central Hospital
Division name Department of Pharmacotherapy
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Japan
TEL 052-762-6111
Email kmuro@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiya Narita
Organization Aichi Cancer Center Central Hospital
Division name Department of Pharmacotherapy
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Japan
TEL 052-762-6111
Homepage URL
Email yukiya.narita@aichi-cc.jp

Sponsor
Institute Public Health Research Foundation
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2018 Year 04 Month 10 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036615

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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