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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011687
Receipt No. 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

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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
Email 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
Email thase@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University graduate scool of medicine, department of respiratory medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013662

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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