UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen.
Title of the study (Brief title)	Evaluation study of the need for the diuretics and an antiemetic, in cisplatin containing regimen.
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of the short hydration chemotherapy without diuretics and stroids in cisplatin containing regimen.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Complete Response grade0 rate of creatinin
Key secondary outcomes	Completion rate, Complete Control rate, adverse events, total control rate

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	Day1. The administration of the 5HT3Receptor antagonist and aprepitant 125mg/day, extracellular fluid 500ml+MgSO4 8mmol before CDDP. And, extracellular fluid 500ml again after CDDP. Day2.3 Oral aprepitant 80mg/day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically or cytologically proven malignant tumors 2) select the combination therapy, including cisplatin as first line 3) over 20 years of age 4) ECOG PS 0,1 5) Adequate organ function WBC more than 3,500/mm3 NETRO more than 2,000/mm3 PLT more than 100,000mm3 Hb more than 9.0g/dL AST, ALT under 100IU/L T-BiL under 2.0mg/dL Cre under 1.0mg/dL Ccr(Cockcroft-Gault)more than 50mL/min SpO2 more than 90% 6) consent is obtained in writing for participation in this study
Key exclusion criteria	1)History of administration platinum-based chemotherapy 2)With Serious infectious disease 3)Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 4) A history or cardiac dysfunction 5)With massive pleural effusion or ascites 6)History of serious disease condition 7)History of drug allergy 8) The hope of pregnancy or cases that may pregnant women, pregnant woman 9) Cases of breast-feeding 10) Cases attending physician was deemed inappropriate
Target sample size	70

Research contact person
Name of lead principal investigator	Takashi Yokoi
Organization	Kansai Medical University Hirakata Hospital
Division name	Thoracic oncology
Address	2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL	072-804-0101
Email	yokoit@hirakata.kmu.ac.jp

Public contact
Name of contact person	Maiko Niki
Organization	Kansai Medical University Hirakata Hospital
Division name	Thoracic oncology
Address	2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL	072-804-0101
Homepage URL
Email	nikima@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization	Kansai Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 08 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 16 Day
Anticipated trial start date	2014 Year 08 Month 18 Day
Last follow-up date	2017 Year 08 Month 21 Day
Date of closure to data entry	2017 Year 08 Month 21 Day
Date trial data considered complete	2017 Year 08 Month 21 Day
Date analysis concluded	2017 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 18 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017295