IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
NCT ID: NCT02556593
Last Updated: 2019-04-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-09-30
Study Completion Date
2019-04-30
Brief Summary
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This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
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Detailed Description
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This study is to assess the efficacy of IMRT combined with erlotinib compared with whole-brain radiotherapy for EGFR wild type non-small cell lung cancer with 4-10 brain metastases.
All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.
All patients recruited will be randomly assigned into two groups. Patients in experimental group will receive daily IMRT at 45 Gy in 15 fractions to brain metastases, combined with daily erlotinib of 150mg for three weeks. Patients in control group will receive daily whole-brain radiotherapy at 30 Gy in 10 fractions.
Conditions
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Non-Small Cell Lung Carcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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IMRT & erlotinib
Patients in experimental group receive IMRT and erlotinib: Daily IMRT(45Gy in 15 fractions) to the brain metastases with daily erlotinib(150mg.po) for three weeks
Group Type
EXPERIMENTAL
IMRT
Intervention Type
RADIATION
Daily IMRT at 45 Gy in 15 fractions to brain metastases
erlotinib
Intervention Type
DRUG
erlotinib 150mg daily
whole-brain radiotherapy
Patients in this group receive WBRT at 30Gy in 10 fractions
Group Type
ACTIVE_COMPARATOR
WBRT
Intervention Type
RADIATION
3DCRT at 30 Gy in 10 fractions to whole brain
Interventions
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IMRT
Daily IMRT at 45 Gy in 15 fractions to brain metastases
Intervention Type
RADIATION
WBRT
3DCRT at 30 Gy in 10 fractions to whole brain
Intervention Type
RADIATION
erlotinib
erlotinib 150mg daily
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed NSCLC and wild type EGFR
* 4-10 brain metastases on high quality CT scanning or MRI.
* No previous EGFR-TKI treatment.
* No previous brain radiotherapy.
* More than 4 weeks from last chemotherapy.
* Expected Survival of at least 2 months.
* KPS≥ 70
* RTOG RPA performance status 0-1
* Lab tests should meet these criteria: White blood cell count ≥3×10\^9 /L;Platelet count≥100×10\^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
* Pregnancy test (-)
* Be able to sign informed consent form.
* 4-10 brain metastases on high quality CT scanning or MRI.
* No previous EGFR-TKI treatment.
* No previous brain radiotherapy.
* More than 4 weeks from last chemotherapy.
* Expected Survival of at least 2 months.
* KPS≥ 70
* RTOG RPA performance status 0-1
* Lab tests should meet these criteria: White blood cell count ≥3×10\^9 /L;Platelet count≥100×10\^9 /L;Total bilirubin 1.5 times or less the upper limits of normal (ULN); AST and ALT 1.5 times or less the ULN; Serum creatinine 1.5 times or less the ULN or creatinine clearance rate(CCR) greater than or equal to 60 ml/min.
* Pregnancy test (-)
* Be able to sign informed consent form.
Exclusion Criteria
* With unstable systematical diseases (concluding acute infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, hepatopathy, nephropathy, metabolic diseases)
* With metastases on meninges.
* Taking antiepileptics (phenytoin sodium etc.) at the same time
* Unable to oral medication.
* Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
* With metastases on meninges.
* Taking antiepileptics (phenytoin sodium etc.) at the same time
* Unable to oral medication.
* Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sun Yat-sen University
OTHER
Sponsor Role
lead
Responsible Party
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Hui Liu
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Hui Liu, professor
Role: PRINCIPAL_INVESTIGATOR
Sun yat-sen universtiy cancer center
Locations
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Hui Liu
Guangdong, , China
Site Status
Countries
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China
References
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Other Identifiers
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GASTO1009
Identifier Type: -
Identifier Source: org_study_id
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