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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011411
Receipt No. R000013360
Scientific Title Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment.
Date of disclosure of the study information 2013/08/07
Last modified on 2017/08/10

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Basic information
Public title Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment.
Acronym FONTANA
Scientific Title Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment.
Scientific Title:Acronym FONTANA
Region
Japan

Condition
Condition lung adenocarcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of erlotinib monotherapy for previously treated lung adenocarcinoma without activating EGFR mutation, EML4-ALK gene fusion, K-RAS mutation and MET protein over expression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-Free Survival (PFS)
Key secondary outcomes Response Rate (RR), Overall Survival (OS), Safety, Quality of life (QOL)

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 Maneuver
Interventions/Control_1 Erlotinib 150mg/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) Histologically or cytologically proven stage IIIB, IV or relapsed lung adenocarcinoma.
2) Tumor specimen is available for biomarker analysis
3) Patients without activating EGFR mutation, EML4-ALK fusion gene, K-Ras mutation and MET protein over expression
4) Patients who have previously treated chemotherapy
5) Measurable region evaluable according to the RECIST
6) ECOG performance status of 0-1
7) Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment
8) Patients aged 20 years or older
9) Sufficient function of main organ
10) Patients who are considered to survive for more than 3 months
11) Written informed consent
Key exclusion criteria 1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis
2) Patients with activating EGFR mutation or EML4-ALK fusion gene or K-Ras mutation or MET protein over expression
3) Patients with no history of chemotherapy for lung cancer
4) Patients with uncontrolled ascites, pleural effusion, or pericardial effusion
5) Patients with active severe infections
6) Patients with past history of administration of HER related agents
7) Impossible cases with oral administration
8) Patients with active ophthalmological disease
9) Pregnancy, breast feeding and suspected pregnancy
10) Patients with symptomatic brain metastasis
11) Patients with double cancer
12) Patients with uncontrollable diabetes mellitus
13) Patients with uncontrollable complications
14) Inappropriate patients for this study judged by the physicians
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuma Kishi
Organization Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name Department of Respiratory Medicine
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, JAPAN
TEL 03-3588-1111
Email kazumak@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Takaya
Organization Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Division name Department of Respiratory Medicine
Zip code
Address Department of Respiratory Medicine
TEL 03-3588-1111
Homepage URL
Email hisashi5240@yahoo.co.jp

Sponsor
Institute Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL
Department of Respiratory Medicine
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 虎の門病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
栃木県立がんセンター(栃木県)
東邦大学医療センター大森病院(東京都)
JR東京総合病院(東京都)
順天堂大学医学部附属練馬病院(東京都)
順天堂大学医学部附属浦安病院(千葉県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 05 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
2013 Year 08 Month 07 Day
Last modified on
2017 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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