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

Last updated: October 25, 2017
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasm Metastasis

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02714010
GASTO1014
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who was confirmed non-small cell lung cancer (NSCLC) by histology orcytology, harboring EGFR mutant type (19 and/or 21 exon mutation).

  • Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn'treceive any treatment after diagnosed with brain metastasis) by MRI, couldn't receiveoperation or stereotactic radiosurgery(SRS).

  • Appraisable disease, that is there must be at least one lesion with the longestdiameter>10mm in brain (by brain MRI).

  • Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group(ECOG)performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl,absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; totalbilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase(ALT) andaspartate aminotransferase(AST)< 1.5x ULN in the absence of liver metastases, or < 5xULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated accordingto Cockcroft-gault formula).

  • Patients should be contraceptive during the period of the trial.

Exclusion

Exclusion Criteria:

  • Patients who had received brain radiotherapy or EGFR-TKI before.

  • Patients who can't receive WBRT.

  • Uncontrolled intracranial hypertension after steroid or dehydration therapy.

  • Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wortwhich will interfere with the metabolism of TKI.

  • Patients with interstitial lung disease, significant ocular disease, or seriousuncontrolled systematic disease.

  • Patients who can't take oral tablets, with active peptic ulcer diseases.

  • Pregnancy or breast-feeding women.

Study Design

Total Participants: 601
Study Start date:
August 01, 2015
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Sun Yat-sen University of cancer center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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