UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Title of the study (Brief title)	The randomized phaseII study about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examination about the skin hazard mitigation in the Erlotinib + oral steroid agent combined therapy and Erlotinib to non-small cell lung cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	A two or more-Grade skin adverse event rate
Key secondary outcomes	Adverse events Skin adverse event rate and revelation time A two or more-Grade skin adverse event revelation time Erlotinib administration rate QOL(EuroQol Group EQ-5D-3L)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	erlotinib 150mg/day prednisolone 10mg/ day 4weeks
Interventions/Control_2	erlotinib 150mg/day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Histologically or cytological confirmed non-small cell lung cancer 2. Age: 20years old or older 3. ECOG PS: 0-2 4. Adequate organ function 5. Life expectancy more than 3 months 6. Written informed consent from the patient
Key exclusion criteria	1. History of severe drug allergy 2.Prior treatment with drugs (Gefitinib or Cetuximab)which act on an EGFR system. 3.The patient by whom revelation of a critical adverse event is expected with a prednisolone tablet 4. Pregnant or breast-feeding females 5.Patient of the past of an active interstitial lung obstacle or a merger 6. Uncontrollable infectious disease 7. Uncontrollable peptic ulcer 8. Glaucomatous patient 9. Patient of serious illness skin disease 10. The patient who has critical complications. (Uncontrollable cardiac disease, liver cirrhosis, continuous watery diarrhea) 11. The patient in whom oral ingestion is impossible. 12. Decision of ineligibility by a physician
Target sample size	80

Research contact person
Name of lead principal investigator	Kingo chida
Organization	Hamamatsu University School of Medicine
Division name	Respiratory Medicine, Second Division, Department of Internal Medicine
Address	20-1, 1-chome, Handayama, higashi-ku, Hamamatsu-city, Shizuoka-pref. Japan
TEL	053-435-2263
Email	sagisakas@hospital.iwata.shizuoka.jp

Public contact
Name of contact person	Shinya Sagisaka
Organization	Iwata City Hospital
Division name	Respiratory Medicine
Address	3-512, Ohkubo, Iwata-city, Shizuoka-pref. Japan
TEL	0538-38-5000
Homepage URL
Email	sagisakas@hospital.iwata.shizuoka.jp

Sponsor
Institute	Respiratory Medicine, Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Respiratory Medicine, Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Iwata City Hospital
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	2012 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 22 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry	2014 Year 03 Month 01 Day
Date trial data considered complete	2014 Year 03 Month 01 Day
Date analysis concluded	2016 Year 03 Month 31 Day

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

Management information
Registered date	2012 Year 02 Month 16 Day
Last modified on	2016 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008618