UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005887 |
|---|---|
| Receipt number | 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 17:32:32 |
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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
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
fushida@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
