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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031910
Receipt No. R000036439
Scientific Title A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Date of disclosure of the study information 2018/04/01
Last modified on 2018/09/25

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Basic information
Public title A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Acronym A randomized study of furosemide or mannitol in short hydration chemotherapy
Scientific Title A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Scientific Title:Acronym A randomized study of furosemide or mannitol in short hydration chemotherapy
Region
Japan

Condition
Condition Chemotherapy naive thoracic malignancy
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the utility of furosemide compared with mannitol in cisplatin-based chemotherapy(>=60mg/m2) using short hydration in chemotherapy naive patients with thoracic malignancy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The proportion of patients experienced >=Grade1 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the upper limit of the normal range (ULN) for serum creatinine at each institute)
Key secondary outcomes 1)The proportion of patients experienced >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute)
2) The proportion of patients experienced >=Grade1 and >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the pretreatment baseline creatinine score in each patient)
3) The proportion of patients experienced >=Grade1 and >=Grade2 renal dysfunction after the completion of forth cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute and on the pretreatment baseline creatinine score in each patient)
4)The proportion of patients with phlebitis and severity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 20% mannitol 300ml, in 30min
Interventions/Control_2 furosemide 20mg, intravenous infusion
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)Thoracic malignancy
2)ECOG PS 0-1
3)Creatinine clearance rate of >=60mL/min
4)Previously untreated with cisplatin-based chemotherapy
Key exclusion criteria With Superior Vena Cava syndrome
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address 811-1, Kimiidera, Wakayama-city
TEL 073-441-0619
Email nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eriko Murakami
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address 811-1, Kimiidera, Wakayama-city
TEL 073-441-0619
Homepage URL
Email erikom@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization none
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 和歌山県立医科大学附属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 07 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
2018 Year 03 Month 26 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036439

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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