Clinical trial NCT02714010: EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
Official title: Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: EGFR-TKI
whole brain radiotherapy
brain metastasis
non-small cell lung cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
* Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
* Appraisable disease, that is there must be at least one lesion with the longest diameter\>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; total bilirubin \< 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）\< 1.5x ULN in the absence of liver metastases, or \< 5x ULN in case of liver metastases. Creatinine clearance \> 60ml/min (calculated according to Cockcroft-gault formula).
* Patients should be contraceptive during the period of the trial.

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 Wort which will interfere with the metabolism of TKI.
* Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
* Patients who can't take oral tablets, with active peptic ulcer diseases.
* Pregnancy or breast-feeding women.

Primary outcomes:
measure: intracranial PFS (iPFS)
timeFrame: up to 41 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: up to 77 months
measure: objective response rate (ORR)
timeFrame: up to 41 months
Other outcomes:
measure: cognitive impairment
timeFrame: up to 77 months
measure: quality of life (QoL)
timeFrame: up to 77 months
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University of cancer center
state: Guangdong
Study officials:
affiliation: associate chief physician
name: li-kun Chen
role: PRINCIPAL_INVESTIGATOR
References: