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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023176
Receipt No. R000026653
Scientific Title Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy
Date of disclosure of the study information 2016/07/14
Last modified on 2016/07/14

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Basic information
Public title Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy
Acronym Hyper short-hydration of cisplatin
Scientific Title Safety and feasibility study of hyper short-hydration with furosemide in cisplatin combinated chemotherapy
Scientific Title:Acronym Hyper short-hydration of cisplatin
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and feasibility of the cisplatin containing chemotherapy with hyper short-hydration in patients with non-small cell lung cancer (NSCLC).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The proportion of patients without renal dysfunction, defined as the proportion of patients without a Grade 2 or higher elevation in creatinine from the baseline value after first-cycle.
Key secondary outcomes ・The proportion of patients without a Grade 2 or higher elevation in creatinine from the baseline value after all cycles
・Adverse events
・Creatinine, eGFR and Ccr after six months from the start of treatment
・The overall response rate
・Progression-free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Hyper short-hydration therapy with cisplatin/pemetrexed, cisplatin/pemetrexed/bevacizumab, or cisplatin/gemcitabine
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)Histologically or cytologically proven non-squamous NSCLC
(2)Clinical stage IIIB (not amenable to curative radiation or surgery), IV or recurrent disease
(3)Regardless of the presence of mesurable lesions
(4) Age of 20 years or older and younger than 75 years at the time of consent
(5)Patients who had not received any prior cytotoxic systemic chemotherapy
(If patients have received adjuvant chemotherapy, the patients who experience recurrence after 6 months are permitted.)
(6)Patients who do not need palliative radiotherapy or drainage concurrently with systemic chemotherapy
(7)Patients who have not received ratiotherapy to the primary lesion
(8)More than 4 weeks after the last operation
(9)ECOG Performance Status (PS) 0-1
(10)Have adequate organ function within 14 days before study entry
(11)Estimated life expectancy at least 3 months
(12)Written informed consent
[the case of CDDP/PEM/BEV]
(13)Proteinuria 0 - 1+
(14)PT-INR 1.5 or less (except for patients received preventive anticoagulation therapy)
Key exclusion criteria (1)Having serious complications
(2)Have any evidence of interstitial lung disease on chest X-ray or CT
(3)Have another active malignancy
(4)Currently have a cardiac or a thoracic effusion which requires treatment
(5)Pregnant or lactating woman
(6)Positive for HBs antigen
(7)Patients whose participation in the trial is judged to be inappropriate by the doctor
[the case of CDDP/PEM/BEV]
(8)History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL
(9)Have possibly complication related to bleeding episode
(10)Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging, or evidence of cavitation in intra-thoracic lesion
(11)Evidence of tumor invading segmental bronchus
(12)Uncontrollable hypertention
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshige Yoshioka
Organization Kurashiki central hospital
Division name Department of Respiratory Medicine
Zip code
Address Miwa1-1-1, Kurashiki, Okayama, Japan
TEL 086-422-0210
Email hirotin@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tae Tanaka
Organization Kurashiki central hospital
Division name Department of Respiratory Medicine
Zip code
Address Miwa1-1-1, Kurashiki, Okayama, Japan
TEL 086-422-0210
Homepage URL
Email tt14837@kchnet.or.jp

Sponsor
Institute Kurashiki central hospital
Institute
Department

Funding Source
Organization Kurashiki central hospital
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 先端医療センター病院(兵庫県)、倉敷中央病院(岡山)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 14 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
2016 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 14 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
2016 Year 07 Month 14 Day
Last modified on
2016 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026653

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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