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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026883
Receipt No. R000027877
Scientific Title Follow-up study of two phase II trials of capecitabine plus oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) as adjuvant therapy after curative resection of gastric cancer.
Date of disclosure of the study information 2017/04/10
Last modified on 2018/10/09

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Basic information
Public title Follow-up study of two phase II trials of capecitabine plus oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) as adjuvant therapy after curative resection of gastric cancer.
Acronym Follow-up study of two phase II trials of capecitabine plus oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) as adjuvant therapy after curative resection of gastric cancer.
Scientific Title Follow-up study of two phase II trials of capecitabine plus oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) as adjuvant therapy after curative resection of gastric cancer.
Scientific Title:Acronym Follow-up study of two phase II trials of capecitabine plus oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) as adjuvant therapy after curative resection of gastric cancer.
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the long-term prognosis and recurrence of patients in full analysis set of two phase II trials of adjuvant chemotherapy of capecitabine plus oxaliplatin (CapeOX) or S-1 plus oxaliplatin (SOX) for patients with gastric cancer after curative gastrectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease free survival
Overall survival
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients in full set analysis of J-CLASSIC-PII or SOXaGC trial
Key exclusion criteria none
Target sample size 162

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Shitara
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa City, Chiba, Japan
TEL 04-7133-1111
Email kshitara@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa City, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Department of Gastrointestinal Oncology, National Cancer Center Hospital East
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 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 Completed
Date of protocol fixation
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective cohort study

Management information
Registered date
2017 Year 04 Month 06 Day
Last modified on
2018 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027877

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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