UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032172
Receipt No. R000015528
Scientific Title Efficacy on prophylactic topical steroid for rash in patients treated eith Erlotinib
Date of disclosure of the study information 2018/04/10
Last modified on 2018/04/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy on prophylactic topical steroid for rash in patients treated eith Erlotinib
Acronym Efficacy on prophylactic topical steroid for rash in patients treated eith Erlotinib
Scientific Title Efficacy on prophylactic topical steroid for rash in patients treated eith Erlotinib
Scientific Title:Acronym 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
1st name
Middle name
Last name Minoru Sakata
Organization Showa University Northern Yokohama Hospital
Division name pharmaceutical department
Zip code
Address 35-1 chigasaki,tudukiku,yokohama,kanagawa
TEL 045-949-7000
Email msdrs@cmed.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Sakata
Organization Showa University Northern Yokohama Hospital
Division name pharmaceutical department
Zip code
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)

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
2018 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 10 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.