UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.
Title of the study (Brief title)	Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.
Region	Japan

Condition
Condition	lung adenocarcinoma
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore efficacy and safety of erlotinib in patients with lung adenocarcinoma harbouring EGFR mutations and previously untreated brain metastases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Event Free Survival: EFS
Key secondary outcomes	Response rate, Response rate of brain metastases, Progression free survival, Overall survival, Local therapy free interval for brain metastases, Duration of treatment with erlotinib

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	erlotinib 150mg/day orally
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)Histologically or cytologically confirmed diagnosis on lung adenocarcinoma. 2)Stage IV or recurrent disease after surgery. 3)Patients harboring active EGFR mutation(exon 19 deletion or L858R) without T790M. 4)Patients with brain metastases confirmed by MRI or CT. 5)The presence of measureable lesion by RECIST. 6)Patients with no prior treatment with EGFR-TKIs. 7)Patients with no prior radiotherapy to brain metastases. 8)Patients with no prior radiotherapy to lung. 9)Age of 20 years or older. 10)Performance Status(ECOG) 0-2. 11)Adequate organ function 12)Interval Palliative radiotherapy >= 2weeks Surgery >= 4weeks Chest or Pericardial drainage>= 2weeks 13)Life expectancy more than 3 months. 14)Written informed consent to participate.
Key exclusion criteria	1)Symptomatic brain metastasis. 2)Patients with untreated brain metastases of size 3cm or more. 3)Active synchronous malignant neoplasm. 4)Uncontrolled pleural effusion, ascites, or pericardial effusion. 5)Active infection requiring systemic administration of antiviral agents, antifungal agents, or antibiotics. 6)Severe complications. 7)Interstitial pneumonia or pulmonary fibrosis detectable on Xray. 8)History of severe drug allergy 9)Patients unable to be treated with oral medication. 10)Pregnancy or lactating patients. 11)Uncontrolled psychotic disease. 12)Patients who were judged inappropriate to entry this study by physician.
Target sample size	25

Research contact person
Name of lead principal investigator	Shinzoh Kudoh
Organization	Osaka City University Hospital
Division name	Departoment of Respiratory Medicine
Address	1-5-7,asahimachi,Abeno-ku,Osaka,Japan
TEL	06-6646-6170
Email	shinzohykudoh@med.osaka-cu.ac.jp

Public contact
Name of contact person	Asuka Tsuya
Organization	Osaka city General Hospital
Division name	Department of clinical oncology
Address	2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka 534,Japan
TEL	06-6929-1221
Homepage URL
Email	a-tsuya@med.osakacity-hp.or.jp

Sponsor
Institute	Osaka city General Hospital
Institute
Department

Funding Source
Organization	Osaka city General Hospital
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	大阪市立大学医学部付属病院、大阪市立総合医療センター、近畿中央胸部疾患センター、淀川キリスト病院、ベルランド総合病院

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 25 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 22 Day
Anticipated trial start date	2013 Year 10 Month 04 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	2014 Year 03 Month 24 Day
Last modified on	2018 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015609