Unique ID issued by UMIN | UMIN000011986 |
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Receipt number | R000014007 |
Scientific Title | A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer |
Date of disclosure of the study information | 2013/10/08 |
Last modified on | 2013/10/08 02:41:35 |
A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Japan |
non-squamous non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
Evaluate efficacy and safety of erlotinib therapy for 3/4
Stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
Disease Control Rate, Progression-free survival, Overall survival, Surgery rate, Pathological Complete Response Rate, Complete resection rate, Safety, Biomarker
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Erlotinib 150mg/day
20 | years-old | <= |
Not applicable |
Male and Female
1)stage III/IV non-squamous non-small cell lung cancer
2) EGFR gene mutation positive
3) Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*whole-brain irradiation(WBRT):2weeks
*stereotactic irradiation(SRI):1day
*irradiation of bone metastases:1day
*palliative radiotherapy:2weeks
*operation(surgery without lobectomy):4weeks
*operation(endoscopic surgery without lobectomy):2weeks
*biopsy with incision, port custody, and treatment to injury:1week
*pleurodesis:2weeks
*chest drainage:1weeks
8)adequate bone marrow,liver,and renal functions
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0g/dL
*AST and ALT, x 2.5 of upper limit of
normal (ULN) or less
*Total bilirubin <= 1.5mg/dL
*Serum creatinin, x 1.5mg/dL of ULN or less
*SpO2(Room air) >=90%
* PT-INR < 1.5
*Protein urea <= 1+
9)a life expectancy of 3 months or more
10)written informed consent
1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known EGFR-TKI resistance gene mutation(T790M) positive
3)history of erlotinib or gefitinib treatment
4)inable of oral drug administration
5)history of myocardial infarction and cerebral infarction within one year
6)planned surgery within study term
7)history of drug allergy
8)massive,pleural effusion or ascites
9)uncontrolled infection or serious medical complications
10)active concomitant malignancy
11)mental disorder
12)pregnant or or lactating women or those who declined contraception
13)those judged not suitable by the attending physician
21
1st name | |
Middle name | |
Last name | Toshinari Ema |
Itabashi central medical center
Department of Thoracic Surgery
2-12-7 Azusawa, Itabashi, Tokyo 174-0051
03-3967-0572
toshinariema09@yahoo.co.jp
1st name | |
Middle name | |
Last name | Toshinari Ema |
Itabashi central medical center
Department of Thoracic Surgery
2-12-7 Azusawa, Itabashi, Tokyo 174-0051
03-3967-0572
toshinariema09@yahoo.co.jp
Itabashi central medical center
none
Self funding
NO
2013 | Year | 10 | Month | 08 | Day |
Unpublished
Preinitiation
2013 | Year | 07 | Month | 30 | Day |
2013 | Year | 08 | Month | 31 | Day |
2016 | Year | 07 | Month | 30 | Day |
2013 | Year | 10 | Month | 08 | Day |
2013 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014007
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