Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
NCT ID: NCT00660504
Last Updated: 2014-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2008-04-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Amrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
2
Etoposide-Cisplatin combined chemotherapy
Etoposide-Cisplatin combined chemotherapy
combined chemotherapy
Interventions
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Amrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
Etoposide-Cisplatin combined chemotherapy
combined chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Extensive disease
* No prior chemotherapy regimen
* Age 18 years or older
* ECOG performance status of 0-1
Exclusion Criteria
* Treatment (Surgical or radiotherapy)of primary tumor
* Interstitial pneumonia or pulmonary fibrosis
* Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
18 Years
ALL
No
Sponsors
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Sumitomo Pharma (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yan Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital Chinese Academy of Medical Science
Locations
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Fuzhou, Fujian, China
Lanzhou, Gansu, China
Guangzhou, Guangdong, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Dalian/Shenyang, Liaoning, China
Shenyang, Liaoning, China
Xian, Shanxi, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Beijing, , China
Shanghai, , China
Tianjin, , China
Countries
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References
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Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.
Other Identifiers
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D0750018
Identifier Type: -
Identifier Source: secondary_id
D0750018
Identifier Type: -
Identifier Source: org_study_id
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