Clinical trial NCT02556593: IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
Official title: IMRT Combined With Erlotinib Compared With Whole-brain Radiotherapy for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Carcinoma
Keywords: Non-Small Cell Lung Cancer
IMRT
erlotinib
whole-brain radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CNS progression free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Hui Liu
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu, professor
role: PRINCIPAL_INVESTIGATOR
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