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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004727
Receipt No. R000005629
Scientific Title Feasibility study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Date of disclosure of the study information 2010/12/15
Last modified on 2012/06/18

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Basic information
Public title Feasibility study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Acronym Feasibility study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Scientific Title Feasibility study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Scientific Title:Acronym Feasibility study of cisplatin-based chemotherapy with short hydration for lung cancer patients
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of short hydration in cisplatin-based chemotherapy for lung cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients without grade 2 or worse elevation of creatinine after cisplatin-based chemotherapy
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 hydration, antiemetics
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
74 years-old >
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically diagnosed lung cancer
2. Cisplatin (75mg/m2 or over)-based chemotherapy
3. Without treatment history of cisplatin
4. 20-74 year old
5. ECOG Performance Status 0 - 1
6. Appropriate organ function
7. Normal kidney function
(1) Cr value under normal limit
(2) Creatinine clearance over 60ml/min
Key exclusion criteria 1. Comorbidity (congestive heart failure, angina, myocardial infarction)
2. Pleural effusion, pericardial effusion, ascites, brain metastases, bone metastases which needs intervention
3. Active infection
4. Steroid treatment
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohide Tamura
Organization National Cancer Center Hospital
Division name Thoracic oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidehito Horinouchi
Organization National Cancer Center Hospital
Division name Thoracic oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization
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
2010 Year 12 Month 15 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
2010 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2010 Year 12 Month 15 Day
Last modified on
2012 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005629

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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