IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases

Study Overview
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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.

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.

Official Title
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IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases

Conditions
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Non-Small Cell Lung Carcinoma

Intervention / Treatment
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* Radiation: IMRT
* Radiation: WBRT
* Drug: erlotinib


Participation Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT & erlotinib<br>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 | Radiation: IMRT<br>* Daily IMRT at 45 Gy in 15 fractions to brain metastases<br>Drug: erlotinib<br>* erlotinib 150mg daily<br>|
| Active Comparator: whole-brain radiotherapy<br>Patients in this group receive WBRT at 30Gy in 10 fractions | Radiation: WBRT<br>* 3DCRT at 30 Gy in 10 fractions to whole brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNS progression free survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, IMRT, erlotinib, whole-brain radiotherapy