UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032172 |
|---|---|
| Receipt number | 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 22:48:55 |
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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
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
msdrs@cmed.showa-u.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015528
