UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021340 |
|---|---|
| Receipt number | R000024610 |
| Scientific Title | A phase2 trial ofAbraxane Oxaliplatin S1 and Itraconazole for unresectable gastric cancer |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/04 14:28:46 |
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Basic information
Public title
A phase2 trial ofAbraxane Oxaliplatin S1 and Itraconazole for unresectable gastric cancer
Acronym
A phase2 trial ofAbraxane Oxaliplatin S1 and Itraconazole for unresectable gastric cancer
Scientific Title
A phase2 trial ofAbraxane Oxaliplatin S1 and Itraconazole for unresectable gastric cancer
Scientific Title:Acronym
A phase2 trial ofAbraxane Oxaliplatin S1 and Itraconazole for unresectable gastric cancer
Region
| Japan |
Condition
Condition
Unresectable gastric cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficiency of Abraxane Oxaliplatin S-1 and Itraconazole for unresectable gastriccancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival, Progression free survival, Disease conctrol rate, adverse event
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unresectable stage3b gastric cancer
Stage 4 gastric cancer
metachronous recurrence
Key exclusion criteria
Severe complication
Favor up over 38.0 degree
Diarrhea over four times in a day
Clinical problem for each patient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sonoda |
Organization
Meiwa Hospital
Division name
Oncology
Zip code
Address
4-31 Agenaruo-cho, Nishinomiya, Hyogo
TEL
0798-47-1767
n_beppu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sonoda |
Organization
Meiwa Hospital
Division name
Oncology
Zip code
Address
Nishinomiya Agenaruo 4-31
TEL
0798-47-1767
Homepage URL
n_beppu@yahoo.co.jp
Sponsor or person
Institute
Meiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the size of tumor after 4 weeks from the first treatment chemotherapy
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024610
