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

• Status: Terminated
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Erlotinib Hydrochloride

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