Unique ID issued by UMIN | UMIN000015414 |
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Receipt number | R000017924 |
Scientific Title | Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer |
Date of disclosure of the study information | 2014/10/11 |
Last modified on | 2018/04/16 12:55:44 |
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer
Japan |
advanced EGFR mutation-positive non-squamous non-small cell lung cancer
Pneumology | Hematology and clinical oncology | Adult |
Malignancy
YES
Prior to the initiation of treatment for advanced or postoperative recurrence EGFR mutation-positive non-squamous non-small cell lung cancer, we ask questions on the treatment to the patients. We select the treatment that the patient desires, to assess the efficacy and safety.
Safety,Efficacy
Exploratory
Not applicable
Progression free survival
Overall survival, Response rate, Adverse events, QOL
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
3
Treatment
Medicine |
EGFR-TKI monotherapy (gefitinib, erlotinib or afatinib)
maintenance therpy of gefitinib plus pemetrexed after gefitinib, carboplatin plus pemetrexed concurrent therapy
erlotinib plus bevacizumab therapy involving the insertion of the bevacizumab, cisplatin plus pemetrexed combination therapy
20 | years-old | <= |
Not applicable |
Male and Female
1.Cytologically or histologically documented non-squamous non-small cell lung cancer
2.EGFR activating mutation positive
3.Stage III without any indications for radiotherapy, Stage IV, or postoperative recurrence
4.chemotherapy naive
5.Prior palliative radiotherapy
1)Except to the primary pulmonary lesion
2)more than two weeks after palliative radiotherapy for bone metastasis
6.Evaluable lesions (Measuarable lesions are not necessary)
7.20 years of age or older at the time of consent
8.ECOG PS 0-1
9.Have adequate organ function within two weeks before study entry
10.Have signed an informed consent
11.Estimated life expectancy of at least 3 months
1.EGFR mutation Exon20 T790M positive
2.Symptomatic brain metastasis and a spinal metastases requiring surgical treatment or irradiation
3.Less than 5 years of disease-free interval with other malignancy
4.Pleural effusion, ascites or pericardial fluid in need of treatment
5.SVC syndrome
6.Spinal cord compression with symptoms
7.Cerebrovascular disorder with aymptoms
8.Unhealed fracture
9.Severe infection
10.Planned surgery during the study period
11.Obvious interstitial lung disease
12.Severe gastrointestinal disorder
13.Symptomatic corneal disease
14.Severe cardiac disease
15.Clinically significant drug allergy
16.Prior EGFR-TKI therapy
17.During pregnabcy or lactating woman
18.Uncontrolled psychiatric disease
19.Other
40
1st name | |
Middle name | |
Last name | Fumio Imamura |
Osaka Medical Center for Cardiovascular diseases
Department of Thoracic Oncology
1-3-3 Nakamichi Higashinari-ku, Osaka
06-6972-1181
imamura-fu@mc.pref.osaka.jp
1st name | |
Middle name | |
Last name | Kazumi Nishino |
Osaka Medical Center for Cardiovascular diseases
Department of Thoracic Oncology
1-3-3 Nakamichi Higashinari-ku, Osaka
06-6972-1181
nisino-ka@mc.pref.osaka.jp
Department of Thoracic Oncology
Osaka Medical Center for Cardiovascular diseases
no
Self funding
NO
大阪府立成人病センター(大阪府)
2014 | Year | 10 | Month | 11 | Day |
Unpublished
Terminated
2014 | Year | 10 | Month | 08 | Day |
2014 | Year | 10 | Month | 20 | Day |
2016 | Year | 10 | Month | 19 | Day |
2018 | Year | 10 | Month | 19 | Day |
2018 | Year | 10 | Month | 19 | Day |
2018 | Year | 10 | Month | 19 | Day |
2014 | Year | 10 | Month | 11 | Day |
2018 | Year | 04 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017924
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