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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005887
Receipt No. R000006948
Scientific Title Randomized phase II study of Valproic acid + weekly paclitaxel in unresectable advanced/recurrent gastric cancer
Date of disclosure of the study information 2011/08/01
Last modified on 2016/03/30

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Basic information
Public title Randomized phase II study of Valproic acid + weekly paclitaxel in unresectable advanced/recurrent gastric cancer
Acronym Phase II study of valproic acid + weekly paclitaxel in gastric cancer
Scientific Title Randomized phase II study of Valproic acid + weekly paclitaxel in unresectable advanced/recurrent gastric cancer
Scientific Title:Acronym Phase II study of valproic acid + weekly paclitaxel in gastric cancer
Region
Japan

Condition
Condition Patients with unresectable advanced/recurrent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the efficacy of weekly paclitaxel combined with valproic acid for unresectable gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes progression free survival
response rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Valproic acid 15mg/kg/day p.o.
Interventions/Control_2 weekly paclitaxel 80mg/m2/D1, 8, 15/ q4w
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 confirmed as gastric cancer
2) PS 0-2
3) Prior therapy < 3
4) 4 weeks later from the end of prior chemo (radio)therapy
5) Sufficient function of important organs
6) Life expectancy > 2 months
7) Patients who can take medication orally
8) Wirtten informed consent
Key exclusion criteria 1) Pregnant women or women who like to be pregnant
2) History of allergy against Cremophol EL
3) Intestinal pneumonia, lung fibrosis, and severe COPD
4) Clinically important infection or acute inflammation
5) Psychological disease
6) Other severe complication or malignancy
7) CNS metastasis
8) Doctor's dicision not to be registered to this study
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachio Fushida
Organization Kanazawa University Hospital
Division name Gastroenterological Surgery
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2362
Email fushida@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachio Fushida
Organization Kanazawa University Hospital
Division name Gastroenterological Surgery
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2362
Homepage URL
Email fushida@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization DDSO (Digestive Disease Support Organization)
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
2011 Year 08 Month 01 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
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 30 Day
Last modified on
2016 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006948

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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