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EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02714010
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Brief Summary:
This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: EGFR-TKI Radiation: whole brain radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis
Study Start Date : August 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Arm 1
Patients take EGFR-TKI alone till tumor progression
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Tarceva/Icotinib

Active Comparator: Arm 2
Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Tarceva/Icotinib

Radiation: whole brain radiotherapy
Other Name: WBRT

Primary Outcome Measures :
  1. intracranial PFS (iPFS) [ Time Frame: up to 41 months ]
    Compare intracranial PFS (iPFS) of two arms

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: up to 77 months ]
  2. objective response rate (ORR) [ Time Frame: up to 41 months ]

Other Outcome Measures:
  1. cognitive impairment [ Time Frame: up to 77 months ]

  2. quality of life (QoL) [ Time Frame: up to 77 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
  • Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery(SRS).
  • Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).
  • Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group(ECOG) performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).
  • Patients should be contraceptive during the period of the trial.

Exclusion Criteria:

  • Patients who had received brain radiotherapy or EGFR-TKI before.
  • Patients who can't receive WBRT.
  • Uncontrolled intracranial hypertension after steroid or dehydration therapy.
  • Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
  • Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
  • Patients who can't take oral tablets, with active peptic ulcer diseases.
  • Pregnancy or breast-feeding women.

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 identifier (NCT number): NCT02714010

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Contact: li-kun Chen 13798019964

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China, Guangdong
Sun Yat-sen University of cancer center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: li-kun chen, doctor    13798019964      
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: li-kun Chen associate chief physician
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Responsible Party: Li-kun Chen, Associate Professor/Associate chief physician, Sun Yat-sen University Identifier: NCT02714010    
Other Study ID Numbers: GASTO1014
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Li-kun Chen, Sun Yat-sen University:
whole brain radiotherapy
brain metastasis
non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action