UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009499 |
|---|---|
| Receipt number | R000011139 |
| Scientific Title | The feasibility study of cisplatin-containing combination chemotherapy with a short hydration regimen for advanced gastric cancer |
| Date of disclosure of the study information | 2012/12/07 |
| Last modified on | 2012/12/06 21:00:05 |
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Basic information
Public title
The feasibility study of cisplatin-containing combination chemotherapy with a short hydration regimen for advanced gastric cancer
Acronym
The feasibility study of cisplatin-containing combination chemotherapy with a short hydration regimen for advanced gastric cancer
Scientific Title
The feasibility study of cisplatin-containing combination chemotherapy with a short hydration regimen for advanced gastric cancer
Scientific Title:Acronym
The feasibility study of cisplatin-containing combination chemotherapy with a short hydration regimen for advanced gastric cancer
Region
| Japan |
Condition
Condition
advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of cisplatin-containing combination chemotherapy with a short hydration regimen for advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of nephrotoxicity
Key secondary outcomes
Incidence of adverse event other than nephrotoxicity, response rate, progression free survival, Cisplatin treatment completion rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cisplatin-containing combination chemotherapy with a short hydration
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
1.ECOG Performance status(PS) of 0-2
2.Patients who have not been treated systemic chemotherapy within the past 5 years
3.Patients who is possible of ingestion
4.The estimated Ccr of 60mL/min or higher
5.Written informed consent
Key exclusion criteria
1.with severe diseases (hepatic failure, pulmonary disease, heart failure, hematologic disorder)
2.with uncontrollable DM
3.with active double cancer
4.pregnant and/or nursing women
5.symptomatic psychological disease
6.HBs-Ag positive and/or HCV-Ab positive
7.with active infection
8.any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichirou Nasu |
Organization
Okayama University Hospital
Division name
Department of gastroenterology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
+81-86-235-7219
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Hospital
Division name
Department of gastroenterology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
+81-86-235-7219
Homepage URL
Sponsor or person
Institute
Department of gastroenterology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 12 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
Management information
Registered date
| 2012 | Year | 12 | Month | 06 | Day |
Last modified on
| 2012 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011139
