UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002861 |
|---|---|
| Receipt number | R000003492 |
| Scientific Title | A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations. |
| Date of disclosure of the study information | 2009/12/08 |
| Last modified on | 2013/01/30 13:34:18 |
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Basic information
Public title
A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.
Acronym
A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.
Scientific Title
A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.
Scientific Title:Acronym
A phase II study of erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate efficacy and safety of Erlotinib for patients with pretreated non-small cell lung cancer with brain metastasis and sensitive EGFR mutations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Efficacy for brain metastasis,
Disease Control Rate,
Progression Free Survival,
Overall Survival,
Evaluation of safety
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 monotherapy
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)Recurrent non-small cell lung cancer already treated with at least one regimens of chemotherapy
3)Patients having EGFR mutation (exon 19 deletion or L858R)
4)No prior treatment with EGFR-TKIs
5)Patients who have at least one measurable lesion, one must be brain lesion, by RECIST.
In the case Stereotactic irradiation such as gammma knives is eligible, those treatment can be priority. After those treatmen, patients are eligible if the measurable brain lesion still remain.
6)Performance status(ECOG):0-3
7)Able to be intensely monitored at least for 2 weeks
8)Patients aged 20 years or older
9)Adequate organ functions, evaluated within 2 weeks before enrollment, as;
a) WBC >= 3,000/mm3
b) Netrophile >= 1,500/mm3
c) Plt >= 100,000/mm3
d) AST/ALT, x 2 of upper limit of normal or less.
e) T. Bil <= 1.5 g/dL
f) Serum creatinine, x 1.5 of upper limit of normal or less.
g) SpO2 >= 90% as room air
10)Patients are excepted to live over 8 weeks.
11)Written informed consent is required to obtain from each patients at each participating institution
Key exclusion criteria
Patients with at least one of the following conditions are ineligible
1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage
2)Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
3)Patients with infection requiring iv administration of antibiotics and/or antifungal agents
4)Patients who has received HER modulator medicine in the past
5)Patients unable to be treated with PO drugs
6) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis
7)Pregnant or breast feeding
8) Active synchronous malignancies
9) Uncontrolled diabetes mellitus
10)Other clinically significant complications
11)Patients judged as being in inappropriate condition for this study by physician
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Eto |
Organization
Shizuoka General Hospital
Division name
Respiratory center
Zip code
Address
27-1, 4-chome, Kitaandou, Aoi-ku, Shizuoka Japan
TEL
054-247-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichirou Shishido |
Organization
Shizuoka General Hospital
Division name
Respiratory medicine
Zip code
Address
27-1, 4-chome, Kitaandou, Aoi-ku, Shizuoka Japan
TEL
054-247-6111
Homepage URL
shishido@general-hosp.pref.shizuoka.jp
Sponsor or person
Institute
Shizuoka General Hospital Respiratory center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka Cancer Center Division of Thoracic Oncology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
静岡県立総合病院(静岡県)、静岡県立静岡がんセンター(静岡県)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 08 | 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
| 2009 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 08 | Day |
Last modified on
| 2013 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003492
