UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)
Title of the study (Brief title)	Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectiveness of prophylaxis against side effects associated with Afatinib
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	In 4 weeks time Severe diarrhea expression inhibition rate (Severe diarrhea:Diarrhea that is deemed necessary dose reduction of Afatinib dose reduction criteria defined in the protocol
Key secondary outcomes

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	loperamide,minocyclin,minocycline hydrochloride,azulene sodium sulfonate
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.Non-small cell lung cancer proven by histology and/or cytology 2.EGFR mutation status is positive 3.Performance Status(ECOG)0-2 4.Afatinib has not been administered in the past 5.Chest radiation therapy that has not been enforced within the registration before 4 weeks 6.Adequate organ function 7.20 years or older 8.Written Informed Consent
Key exclusion criteria	(1)History of active double cancer (2)No intention to birth control (3)Unstable psychic disorder (4)Interstitial pneumonia or active radiation pneumonia or drug-induced pneumonia (5)Ileus (6)Patients who can not take oral drugs (7)Severe complications (8)Patients in drug and tetracycline drug used in the present study a history of hypersensitivity (9)Decision of ineligibility by a physician.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Kagamu
Organization	Niigata University Medical & Dental Hospital
Division name	Respiratory and infectious diseases internal medicine
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2200
Email	hkagamu@med.niigata-u.ac.jp

Public contact
Name of contact person	Masaaki Okajima
Organization	Niigata University Medical & Dental Hospital
Division name	Respiratory and infectious diseases internal medicine
Address	1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2200
Homepage URL
Email	okajima-nii@umin.ac.jp

Sponsor
Institute	Niigata Lung Cancer Treatment Group
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	2015 Year 01 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 08 Day
Anticipated trial start date	2015 Year 01 Month 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 09 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018765