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

Phase 2

Terminated

• Conditions: Non-Small Cell Lung Carcinoma
• Interventions: Radiation: IMRT; Radiation: WBRT; Drug: erlotinib

• Registration Number: NCT02556593
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-19
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Status Verified: 2019-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMRT & erlotinib	IMRT	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
whole-brain radiotherapy	WBRT	Patients in this group receive WBRT at 30Gy in 10 fractions
IMRT & erlotinib	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

Primary Outcome Measures

Name	Time	Method
CNS progression free survival	2 years

Trial Locations

Locations (1)

Hui Liu; 🇨🇳 Guangdong, China