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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02556593

Enrollment

Registered

2015-09-22

Start date

2015-09-30

Completion date

2019-04-30

Last updated

2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Carcinoma

Keywords

Non-Small Cell Lung Cancer, IMRT, erlotinib, whole-brain radiotherapy

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.

Interventions

RADIATIONIMRT

Daily IMRT at 45 Gy in 15 fractions to brain metastases

RADIATIONWBRT

3DCRT at 30 Gy in 10 fractions to whole brain

DRUGerlotinib

erlotinib 150mg daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CNS progression free survival	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026