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 not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Shandong Cancer Hospital and Institute
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Jinming Yu, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01714908
First received: October 23, 2012
Last updated: October 26, 2012
Last verified: October 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Progress Free Survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714908

Contacts
Contact: Song Lu, Bachelor 862151088628 ext 8005 song.lu@fountain-med.com
Contact: Cong Cheng, Bachelor 862151088628 ext 8013 cong.cheng@fountain-med.com

Locations
China, Beijing
Cancer Institute & Hospital, Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100021
Contact: Lvhua Wang, PhD    8613601283715    wlhwq@yahoo.com   
Beijing Cancer Hospital Not yet recruiting
Beijing, Beijing, China, 100142
Contact: Guangying Zhu, PhD    8613717999977    zgypu@yahoo.com.cn   
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Tingyi Xia, PhD    8613901380726    68434886@163.com   
China, Fujian
Fujian Province Cancer Hospital Not yet recruiting
Fuzhou, Fujian, China, 350008
Contact: Jiancheng Li, PhD    8613906900190    jianchengli6@126.com   
China, Hebei
Hebei Medical University Fourth Hospital Not yet recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Chun Han, PhD    8613831105846    hanchun2006@yahoo.com.cn   
China, Henan
Henan Cancer Hospital Not yet recruiting
Zhengzhou, Henan, China, 450008
Contact: Jianhua Wang, PhD    8613938278827    jianhua@371.net   
China, Hubei
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Conghua Xie, PhD    8613638607566    Chxie_65@hotmail.com   
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430022
Contact: Gang Wu, PhD    8613871240042    wugangzr@yahoo.com.cn   
China, Liaoning
The First Hospital of China Medical University Not yet recruiting
Shenyang, Liaoning, China, 110001
Contact: Guang Li, PhD    8613804058616    liguang1963@yahoo.com.cn   
China, Shandong
Shandong Cancer Hospital and Institute Not yet recruiting
Jinan, Shandong, China, 250117
Contact: Ligang Xing, PhD    8653167626819    xinglg@gmail.com   
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaolong Fu, PhD    8613651635103    xlfu1964@126.com   
China, Sichuan
West China Hospital, West China School of Medicine, Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: You Lu, PhD    8613981935716    radyoulu@hotmail.com   
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
China, Zhejiang
The First People's Hospital of Hangzhou Not yet recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Shenglin Ma, PhD    8613588799118    mashenglin@medmail.com.cn   
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Ming Chen, PhD    8613609020845    chenming@sysucc.org.cn   
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: Xiaolong Fu, 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 China Medical University, China
Principal Investigator: Zhiyong Yuan, PhD Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Jinming Yu, Professor, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01714908     History of Changes
Other Study ID Numbers: ML28545
Study First Received: October 23, 2012
Last Updated: October 26, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 19, 2014