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

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study ID
NCT01887795
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

First listed
Jun 27, 2013
Start date
Aug 31, 2013
Status verified
Aug 2016
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
224 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. WBRT alone
    Selected 224 patients with multiple brain metastases from NSCLC, they will be randomized to WBRT or Erotinib concurrent WBRT. It was enough to compare the efficacy of Erotinib concurrent WBRT vs. WBRT
  • Experimental: 2. Erlotinib concurrent WBRT
    Selected 224 patients with multiple brain metastases from NSCLC, they will be randomized to WBRT or Erotinib concurrent WBRT. It was enough to compare the efficacy of Erotinib concurrent WBRT vs. WBRT

Primary Outcome Measure

Time to neurologic progression [ Time Frame: 13 months ]

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