UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014878 |
|---|---|
| Receipt number | R000017295 |
| Scientific Title | Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen. |
| Date of disclosure of the study information | 2014/08/18 |
| Last modified on | 2017/08/21 08:28:45 |
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Basic information
Public title
Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen.
Acronym
Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen.
Scientific Title
Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen.
Scientific Title:Acronym
Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen.
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the short hydration chemotherapy without diuretics and stroids in cisplatin containing regimen.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete Response
grade0 rate of creatinin
Key secondary outcomes
Completion rate, Complete Control rate, adverse events, total control 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
Day1.
The administration of the 5HT3Receptor antagonist and aprepitant 125mg/day, extracellular fluid 500ml+MgSO4 8mmol before CDDP. And, extracellular fluid 500ml again after CDDP.
Day2.3
Oral aprepitant 80mg/day.
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
Histologically or cytologically proven malignant tumors
2) select the combination therapy, including cisplatin as first line
3) over 20 years of age
4) ECOG PS 0,1
5) Adequate organ function
WBC more than 3,500/mm3
NETRO more than 2,000/mm3
PLT more than 100,000mm3
Hb more than 9.0g/dL
AST, ALT under 100IU/L
T-BiL under 2.0mg/dL
Cre under 1.0mg/dL
Ccr(Cockcroft-Gault)more than 50mL/min
SpO2 more than 90%
6) consent is obtained in writing for participation in this study
Key exclusion criteria
1)History of administration platinum-based chemotherapy
2)With Serious infectious disease
3)Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
4) A history or cardiac dysfunction
5)With massive pleural effusion or ascites
6)History of serious disease condition
7)History of drug allergy
8) The hope of pregnancy or cases that may pregnant women, pregnant woman
9) Cases of breast-feeding
10) Cases attending physician was deemed inappropriate
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yokoi |
Organization
Kansai Medical University Hirakata Hospital
Division name
Thoracic oncology
Zip code
Address
2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL
072-804-0101
yokoit@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Niki |
Organization
Kansai Medical University Hirakata Hospital
Division name
Thoracic oncology
Zip code
Address
2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL
072-804-0101
Homepage URL
nikima@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
| 2014 | Year | 08 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 21 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 21 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 21 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017295
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
