UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013502 |
|---|---|
| Receipt number | R000015609 |
| Scientific Title | Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations. |
| Date of disclosure of the study information | 2014/03/25 |
| Last modified on | 2018/09/26 09:20:13 |
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Basic information
Public title
Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.
Acronym
Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.
Scientific Title
Phase II study of erlotinib as first line chemotherapy in patients with lung adenocarcinoma with brain metastasis and EGFR mutations.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinzoh Kudoh |
Organization
Osaka City University Hospital
Division name
Departoment of Respiratory Medicine
Zip code
Address
1-5-7,asahimachi,Abeno-ku,Osaka,Japan
TEL
06-6646-6170
shinzohykudoh@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Tsuya |
Organization
Osaka city General Hospital
Division name
Department of clinical oncology
Zip code
Address
2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka 534,Japan
TEL
06-6929-1221
Homepage URL
a-tsuya@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka city General Hospital
Institute
Department
Personal name
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)
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
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 |
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 22 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015609
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