UMIN-CTR Clinical Trial

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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