Unique ID issued by UMIN | UMIN000015984 |
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Receipt number | R000018474 |
Scientific Title | Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405) |
Date of disclosure of the study information | 2014/12/18 |
Last modified on | 2022/02/04 13:23:35 |
Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405)
Efficacy of crizotinib in alectinib-refractory patients; phase2 trial (OLCSG1405)
Efficacy of crizotinib in alectinib-refractory patients with NSCLC harboring EML4-ALK; phaseII trial (OLCSG1405)
Efficacy of crizotinib in alectinib-refractory patients; phase2 trial (OLCSG1405)
Japan |
Non-small cell lung cancer harboring EML4-ALK
Pneumology |
Malignancy
NO
To clarify the efficacy and safety of crizotinib in alectinib refractory patients with advanced non-small cell lung cancer harboring EML4-ALK fusion gene.
Safety,Efficacy
Confirmatory
Phase II
Objective response rate
Progression-free survival, overall survival, expression of EML4-ALK and MET, adverse events, quality of life, and survey using the care notebook
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Crizotinib 250 mg oral administration twice per day
20 | years-old | <= |
Not applicable |
Male and Female
Advanced non-small cell lung cancer confirmed by histological or cytological diagnosis.
EML4-ALK fusion gene is positive.
There is no treatment history with ALK inhibitors excluding alectinib. The treatment history with cytotoxic chemotherapy is unquestioned.
Disease stage is III/IV period which is postoperative recurrence or unavailable for surgery or radical irradiation.
Performance status (ECOG scale): 0-2
Patients with symptomatic brain metastases.
Pregnant women, nursing mothers, the women who may be pregnant or have the will to get pregnant, and the men who hope for fertility with pregnancy.
The patients with a history of hypersensitivity to crizotinib.
9
1st name | |
Middle name | |
Last name | Katsuyuki Kiura |
Okayama University Hospital
Department of Respiratory Medicine
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
086-235-7227
kkiura@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Hideko Isozaki |
Okayama University Hospital
Department of Respiratory Medicine
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
086-235-7227
h.isozaki325@gmail.com
Okayama Lung Cancer Study Group
Okayama University
Other
Non
NO
岡山大学病院呼吸器(岡山県)
KKR高松病院(香川県)
下関市立市民病院(山口県)
福山市民病院 (広島県)
岡山赤十字病院(岡山県)
岡山医療センター(岡山県)
南岡山医療センター(岡山県)
岡山労災病院(岡山県)
岡山済生会病院(岡山県)
川崎病院(岡山県)
倉敷中央病院 (岡山県)
神戸赤十字病院(兵庫県)
津山中央病院(岡山県)
呉共済病院(広島県)
福山医療センター(広島県)
尾道市民病院(広島県)
中国中央病院(広島県)
山口宇部医療センター(山口県)
岩国医療センター(山口県)
香川労災病院(香川県)
住友別子病院(愛媛県)
愛媛県立中央病院(愛媛県)
四国がんセンター(愛媛県)
鳥取市民病院(鳥取県)
2014 | Year | 12 | Month | 18 | Day |
Unpublished
Completed
2014 | Year | 12 | Month | 16 | Day |
2014 | Year | 12 | Month | 16 | Day |
2014 | Year | 12 | Month | 18 | Day |
2019 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 17 | Day |
2022 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018474
Research Plan | |
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Registered date | File name |
2017/01/08 | OLCSG1405 プロトコル、アンケート 第2版.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |