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EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

NCT02714010 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2017-10-27

No results posted yet for this study

Summary

This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.

Conditions

Interventions

DRUG

EGFR-TKI

Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid

RADIATION

whole brain radiotherapy

30Gy/10F

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • li-kun Chen · associate chief physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714010 on ClinicalTrials.gov