Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21
NCT ID: NCT01714908
Last Updated: 2017-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2012-12-14
2018-10-20
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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Erlotinib w Concurrent Radiotherapy
erlotinib 150mg oral daily up to 2 years concurrent radiotherapy total dose 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, and 5 fractions per week.
Erlotinib w Concurrent Radiotherapy
etoposide/cis-platin (EP) w Concurrent Radiotherapy
etoposide 50mg/m2 on D1-5 and D29-33 cis-platin 50mg/m2 on D1, D8, D29 and D36 concurrent radiotherapy total 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, 5 fractions per week.
etoposide/cis-platin (EP) w Concurrent Radiotherapy
Etoposide / Cis-platin w Concurrent Radiotherapy
Interventions
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Erlotinib w Concurrent Radiotherapy
etoposide/cis-platin (EP) w Concurrent Radiotherapy
Etoposide / Cis-platin w Concurrent Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable;
* Has active mutation of EGFR in exon 19 or 21;
* Has measurable lesion \[according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension \>= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and \>=15mm\];
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* expectancy life \>= 12 weeks;
Exclusion Criteria
* Had systemic anit-NSCLC treatments;
* Had local radiotherapy for NSCLC;
* Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
* Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
* Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
* Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation;
* Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
18 Years
75 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Jinming Yu
OTHER
Responsible Party
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Jinming Yu
Professor
Principal Investigators
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Jinming Yu, PhD
Role: STUDY_CHAIR
Shandong Cancer Hospital and Institute
Shenglin Ma, PhD
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Hangzhou
Conghua Xie, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhongnan Hospital
Ming Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Gang Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union Hospital
Jianhua Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Henan Cancer Hospital
Jiancheng Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Fujian Province Cancer Hospital
Zhengfei Zhu, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
You Lu, PhD
Role: PRINCIPAL_INVESTIGATOR
West China Hospital, West China School of Medicine, Sichuan University
Lvhua Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Guangying Zhu, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Tingyi Xia, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Chun Han, PhD
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Fourth Hospital
Guang Li, PhD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Zhiyong Yuan, PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Qin Lin, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Xiamen University
Qibin Song, PhD
Role: PRINCIPAL_INVESTIGATOR
Renmin Hospital of Wuhan University
Yaping Xu, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Bing Lu, PhD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital of Guizhou Province
Baolin Qu, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
Fujian Province Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guizhou Cancer Hospital
Guiyang, Guizhou, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, West China School of Medicine, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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ML28545
Identifier Type: -
Identifier Source: org_study_id
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