Back to resultsEGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
Primary Purpose
Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
EGFR-TKI
whole brain radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring EGFR-TKI, whole brain radiotherapy, brain metastasis, non-small cell lung cancer
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-sen University of cancer centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Patients take EGFR-TKI alone till tumor progression
Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
Outcomes
Primary Outcome Measures
intracranial PFS (iPFS)
Compare intracranial PFS (iPFS) of two arms
Secondary Outcome Measures
overall survival (OS)
objective response rate (ORR)
Full Information
NCT ID
NCT02714010
First Posted
November 29, 2015
Last Updated
October 25, 2017
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02714010
Brief Title
EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
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 Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
EGFR-TKI, whole brain radiotherapy, brain metastasis, non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
601 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients take EGFR-TKI alone till tumor progression
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
Intervention Type
Drug
Intervention Name(s)
EGFR-TKI
Other Intervention Name(s)
Gefitinib/Tarceva/Icotinib
Intervention Description
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Intervention Type
Radiation
Intervention Name(s)
whole brain radiotherapy
Other Intervention Name(s)
WBRT
Intervention Description
30Gy/10F
Primary Outcome Measure Information:
Title
intracranial PFS (iPFS)
Description
Compare intracranial PFS (iPFS) of two arms
Time Frame
up to 41 months
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
up to 77 months
Title
objective response rate (ORR)
Time Frame
up to 41 months
Other Pre-specified Outcome Measures:
Title
cognitive impairment
Description
questionnaire
Time Frame
up to 77 months
Title
quality of life (QoL)
Description
questionnaire
Time Frame
up to 77 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li-kun Chen
Phone
13798019964
Email
chenlk@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li-kun Chen
Organizational Affiliation
associate chief physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University of cancer center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
li-kun chen, doctor
Phone
13798019964
12. IPD Sharing Statement
Learn more about this trial
EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
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