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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003313
Receipt No. R000003989
Scientific Title Multicenter Phase II study of erlotinib for advanced or recurrent non-small cell lung cancer with Epidermal Growth factor Receptor (EGFR) mutation (TORG0911)
Date of disclosure of the study information 2010/03/14
Last modified on 2019/02/25

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Basic information
Public title Multicenter Phase II study of erlotinib
for advanced or recurrent non-small cell lung cancer with Epidermal Growth factor Receptor (EGFR) mutation (TORG0911)
Acronym Phase II Study of low dose erlotinib in EGFR mutation Non-Small Cell Lung Cancer(TORG0911)
Scientific Title Multicenter Phase II study of erlotinib
for advanced or recurrent non-small cell lung cancer with Epidermal Growth factor Receptor (EGFR) mutation (TORG0911)
Scientific Title:Acronym Phase II Study of low dose erlotinib in EGFR mutation Non-Small Cell Lung Cancer(TORG0911)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate efficacy and safety of low dose erlotinib for advanced or recurrent Non-small cell lung cancer with EGFR mutation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control rate, response rate in patients who have stable disease after dose escalation , progression free survival, overall survival

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 treatment
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)patients with pathologically proven non-small cell lung cancer
2)patients with stage IIIB or IV who are not candidates for curative radiotherapy
3)patients with prior chemotherapy regimens three or less
4)patients having EGFR mutation (exon 18, exon 19 or Exon 21)
5)no prior treatment with EGFR
tyrosine kinase inhibitor
6)possible cases with oral
administration
7)performance status (ECOG)0-2
8)patient who has measurable lesions by RECIST
9)close and meticulous clinical observation with (or without)
hospitalization during the first four
weeks of treatment
10)patients aged 20 years or older
11)sufficient function of main organ and bone marrow
12)more than 4 weeks after the last chemotherapy
13)signed informed consent
Key exclusion criteria 1)previous radiotherapy to primary lung cancer
2)superior vena caval syndrome
3)severe drug allergy
4)large peritoneal or pericardial
effusion
5)active infection
6)continuous watery diarrhea
7)intestinal paralysis or ileus
8)interstitial pneumonia or lung
fibrosis evident on CT
9)symptomatic ophthalmologic disease
10)current or previous (within the last 1 year) history of GI perforation
11)serious non-healing ulcer
12)Symptomatic or steroid-requiring brain metastases
13),14)active concomitant malignancy
15)uncontrolled diabetes
16)severe cardiac disease
17)severe psychological disease
18)pregnant or lactating women or those who declined contraception
19)those judged to be not suitable by the attending physician
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Kunitoh
Organization Japanese Red Cross Medical Center
Division name Division of Chemotherapy Department of Internal Medicine
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL 03-3400-1311
Email kunito_hideo@med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Kunitoh
Organization Japanese Red Cross Medical Center
Division name Division of Chemotherapy Department of Internal Medicine
Zip code
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL 03-3400-1311
Homepage URL http://www.torg.or.jp/
Email kunito_hideo@med.jrc.or.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26174465
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
2010 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 03 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
2010 Year 03 Month 11 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003989

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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