UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023176
Receipt number 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 22:16:37

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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 or person

Institute

Kurashiki central hospital

Institute

Department

Personal name



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

Value
https://center6.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