Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21
RECEL
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21
1 other identifier
interventional
100
1 country
19
Brief Summary
Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2012
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedStudy Start
First participant enrolled
December 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2018
CompletedFebruary 7, 2017
February 1, 2017
5.7 years
October 23, 2012
February 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress Free Survival (PFS)
The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)
5 years
Study Arms (2)
Erlotinib w Concurrent Radiotherapy
EXPERIMENTALerlotinib 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.
etoposide/cis-platin (EP) w Concurrent Radiotherapy
ACTIVE COMPARATORetoposide 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.
Interventions
Etoposide / Cis-platin w Concurrent Radiotherapy
Eligibility Criteria
You may qualify if:
- NSCLC confirmed by histopathology or cytology;
- 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;
You may not qualify if:
- Had be treated by HER-targeting agents;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jinming Yulead
- Roche Pharma AGcollaborator
Study Sites (19)
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853, China
Fujian Province Cancer Hospital
Fuzhou, Fujian, 350008, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Guizhou Cancer Hospital
Guiyang, Guizhou, 550004, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050011, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, West China School of Medicine, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jinming Yu, PhD
Shandong Cancer Hospital and Institute
- PRINCIPAL INVESTIGATOR
Shenglin Ma, PhD
The First People's Hospital of Hangzhou
- PRINCIPAL INVESTIGATOR
Conghua Xie, PhD
Zhongnan Hospital
- PRINCIPAL INVESTIGATOR
Ming Chen, PhD
Zhejiang Cancer Hospital
- PRINCIPAL INVESTIGATOR
Gang Wu, PhD
Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union Hospital
- PRINCIPAL INVESTIGATOR
Jianhua Wang, PhD
Henan Cancer Hospital
- PRINCIPAL INVESTIGATOR
Jiancheng Li, PhD
Fujian Province Cancer Hospital
- PRINCIPAL INVESTIGATOR
Zhengfei Zhu, PhD
Fudan University
- PRINCIPAL INVESTIGATOR
You Lu, PhD
West China Hospital, West China School of Medicine, Sichuan University
- PRINCIPAL INVESTIGATOR
Lvhua Wang, PhD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Guangying Zhu, PhD
Peking University Cancer Hospital & Institute
- PRINCIPAL INVESTIGATOR
Tingyi Xia, PhD
Chinese PLA General Hospital
- PRINCIPAL INVESTIGATOR
Chun Han, PhD
Hebei Medical University Fourth Hospital
- PRINCIPAL INVESTIGATOR
Guang Li, PhD
First Hospital of China Medical University
- PRINCIPAL INVESTIGATOR
Zhiyong Yuan, PhD
Tianjin Medical University Cancer Institute and Hospital
- PRINCIPAL INVESTIGATOR
Qin Lin, PhD
The First Affiliated Hospital of Xiamen University
- PRINCIPAL INVESTIGATOR
Qibin Song, PhD
Renmin Hospital of Wuhan University
- PRINCIPAL INVESTIGATOR
Yaping Xu, PhD
Zhejiang Cancer Hospital
- PRINCIPAL INVESTIGATOR
Bing Lu, PhD
Cancer Hospital of Guizhou Province
- PRINCIPAL INVESTIGATOR
Baolin Qu, PhD
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 23, 2012
First Posted
October 26, 2012
Study Start
December 14, 2012
Primary Completion
August 20, 2018
Study Completion
October 20, 2018
Last Updated
February 7, 2017
Record last verified: 2017-02