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Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21 (RECEL)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714908
First Posted: October 26, 2012
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Jinming Yu, Shandong Cancer Hospital and Institute
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Other: Erlotinib w Concurrent Radiotherapy Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jinming Yu, Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Progress Free Survival (PFS) [ Time Frame: 5 years ]
    The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first)


Estimated Enrollment: 100
Actual Study Start Date: December 14, 2012
Estimated Study Completion Date: October 20, 2018
Estimated Primary Completion Date: August 20, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Erlotinib w Concurrent Radiotherapy
Active Comparator: 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.
Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy
Etoposide / Cis-platin w Concurrent Radiotherapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714908


Locations
China, Beijing
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
The General Hospital of the People's Liberation Army
Beijing, Beijing, China, 100853
China, Fujian
Fujian Province Cancer Hospital
Fuzhou, Fujian, China, 350008
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
China, Guizhou
Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550004
China, Hebei
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050011
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Hubei
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430030
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
China, Liaoning
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
China, Shandong
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
China, Sichuan
West China Hospital, West China School of Medicine, Sichuan University
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
China, Zhejiang
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China, 310006
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Jinming Yu
Roche Pharma AG
Investigators
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 Wuhan University
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 Beijing Cancer Hospital
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
  More Information

Responsible Party: Jinming Yu, Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01714908     History of Changes
Other Study ID Numbers: ML28545
First Submitted: October 23, 2012
First Posted: October 26, 2012
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Jinming Yu, Shandong Cancer Hospital and Institute:
NSCLC
EGFR mutation
unresectable
erlotinib
concurrent radiotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Erlotinib Hydrochloride
Etoposide
Cisplatin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors