NCT01887795

Phase Ⅲ Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer(ENTER): a Multicentre, Open-label, Randomised Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

1. Verify the effect of Erlotinib concurrent whole-brain radiation therapy as first-line treatment for patients with multiple brain metastases from non-small-cell lung cancer to compare with WBRT alone. 2. Verify pre-built EGFR mutation prediction model for NSCLC brain metastases

Detailed description

All patients will be randomized to receive WBRT or Erlotinib concurrent WBRT. Erlotinib concurrent WBRT, patients were given a loading dose of erlotinib 150mg per day for 6 days, after which all patients received erlotinib 150mg per day concurrently with WBRT. Dose reduction was allowed for intolerable adverse effects (grade ≥3) such as rash or diarrhea in 50 mg increments down from 150mg to 100 mg and then to 50 mg if needed. Radiation therapy was delivered in 2.0 Gy fractions once per day 5 days per week to a total dose of 40Gy (20 fractions). Radiation was delivered as opposed lateral 8-MV beams with a Sweden precise linear accelerator.

Conditions

• Multiple Brain Metastases
• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib
DRUG	WBRT

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-06-27
• Last updated: 2016-08-25

Locations

1 site across 1 country: China