Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
GASTO1014
- NCT ID:
NCT02714010
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
EGFR-TKI | Gefitinib/Tarceva/Icotinib | Arm 1 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | Patients take EGFR-TKI alone till tumor progression | |
Arm 2 | Active Comparator | Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI | |
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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | intracranial PFS (iPFS) |
Time Frame: | up to 41 months |
Safety Issue: | |
Description: | Compare intracranial PFS (iPFS) of two arms |
Secondary Outcome Measures
Measure: | overall survival (OS) |
Time Frame: | up to 77 months |
Safety Issue: | |
Description: | |
Measure: | objective response rate (ORR) |
Time Frame: | up to 41 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Sun Yat-sen University |
Trial Keywords
- EGFR-TKI
- whole brain radiotherapy
- brain metastasis
- non-small cell lung cancer
Last Updated
October 27, 2017