UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy on prophylactic topical steroid for rash in patients treated eith Erlotinib
Title of the study (Brief title)	Efficacy on prophylactic topical steroid for rash in patients treated eith Erlotinib
Region	Japan

Condition
Condition	Non-Small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety on prophylactic topical steroid for rash in patients treated with Erlotinib against pretreated recurrent non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Skin toxicity(Grade2) rate on the face
Key secondary outcomes	resupanse rate progression free survival overall survival safety dose intensity compliance quality of life

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	Hydrocortisone Butyrate 0.1% and Heparinoid 0.3% applied to face every other 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	1)Historogically or cytologically proven stage.3b or 4 non-small cell lung cancer 2)No prior treatment with EGFR-TKIs 3)PS of 0,1 or 2 4)Adequate organ functions,evaluated within 2 weeks before enrollment,as; a)T.Bil<=1.5mg/dL b)sCr<=1.2mg/dL c)SpO2(Room air)>=94% or PaO2>=65mmHg d)AST/ALT<=upper limit of normal within twice 5)Life expaectancy of more than 2 weeks 6)witten informed consent from the patient
Key exclusion criteria	1)Patients with superior vena caval syndrome 2)Patients with compressive spinal cord lesion 3)History of hypersensitivity for drugs 4)Patients with brain metastasis or anticonvulsant medication 5)Patients with severe skin disease or treated by steroid 6)Patients with idiopathic pulomary fibrosis,pneumoconiosis,other interstitial pneumonia,idiopathic pulmonary,drug induced pulmonary damage or lungs inflammation 7)Interval from precious treatment,of following,at enrollment a)Equal or more than 4 weeks after b)Equal or more than 2 weeks after 8)active fluid in the abdomen or pleural effusion 9)Other clinically significant complications 10)Clinically significant eye diseases 11)Patients with diverticulitis 12)History of perforation of the digestive tract within one years 13)Other clinically significant cardiac disease 14)Other clinically significant psychiatric disease 15)Pregnancy,breast feeding and suspecterd pregnancy
Target sample size	14

Research contact person
Name of lead principal investigator	Minoru Sakata
Organization	Showa University Northern Yokohama Hospital
Division name	pharmaceutical department
Address	35-1 chigasaki,tudukiku,yokohama,kanagawa
TEL	045-949-7000
Email	msdrs@cmed.showa-u.ac.jp

Public contact
Name of contact person	Minoru Sakata
Organization	Showa University Northern Yokohama Hospital
Division name	pharmaceutical department
Address	35-1 chigasaki,tudukiku,yokoha
TEL	045-949-7000
Homepage URL
Email	msdrs@cmed.showa-u.ac.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital
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)

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	2018 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 31 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 04 Month 09 Day
Last modified on	2018 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015528