UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011687 |
|---|---|
| Receipt number | R000013662 |
| Scientific Title | A feasibility study of short hydration regimen for lung cancer patients receiving cisplatin-based chemotherapy |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2016/09/12 08:58:05 |
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Basic information
Public title
A feasibility study of short hydration regimen for lung cancer patients receiving cisplatin-based chemotherapy
Acronym
A feasibility study of short hydration regimen for lung cancer patients receiving cisplatin-based chemotherapy
Scientific Title
A feasibility study of short hydration regimen for lung cancer patients receiving cisplatin-based chemotherapy
Scientific Title:Acronym
A feasibility study of short hydration regimen for lung cancer patients receiving cisplatin-based chemotherapy
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the feasibility of short hydration of cisplatin-based chemotherapy for lung cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
proportion of the patients without grade 2 to 4 creatinine elevation based on NCI-CTCAE ver4.0
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)patients with pathologically proven lung cancer
2)patients recieving cisplatin dose of 60mg/m2 or above
3)patients without treatment history of chemotherapy
4)20 years of age or older, 75 years of age or younger
5)appropriate organ function
6)adequate renal function
serum creatinine level under 1.5mg/dl
creatinine clearance over 60ml/min
7)oxigen saturation on room air over 90%
8)Performance status (ECOG) 0-1
9)written informed consent
Key exclusion criteria
1)active infection
2)pregnant or lactating woman and possibility of the pregnancy in the six months after completion of the study
3)a histroy of a severe drug allergy
4)severe comobidity
5)judged to be inappropriate by the attending doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Hasegawa |
Organization
Nagoya University graduate scool of medicine
Division name
department of respiratory medicine
Zip code
Address
65 Tsurumai-cho Showa-ku, Nagoya
TEL
052-744-2167
yhasega@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsunari Hase |
Organization
Nagoya University graduate scool of medicine
Division name
department of respiratory medicine
Zip code
Address
65 Tsurumai-cho Showa-ku, Nagoya
TEL
052-744-2167
Homepage URL
thase@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University graduate scool of medicine, department of respiratory medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University graduate scool of medicine, department of respiratory medicine
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
| 2013 | Year | 10 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2016 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013662
| 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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