UMIN-CTR Clinical Trial

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

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2018

Year

04

Month

09

Day

Last modified on

2018

Year

04

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015528