Lung Cancer, Metastatic Cancer
Conditions
Keywords
tumors metastatic to brain, non-small cell lung cancer, Icotinib
Brief summary
The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.
Detailed description
Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.
Interventions
DRUGIcotinib
Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Cytologic or histological diagnosis of non-small cell lung cancer * Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated * Patients are diagnosed with multiple brain metastases for the first time in 4 weeks * Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI). * Doctors consider the patient will benefit from WBRT * No prior brain radiotherapy * ECOG performance status 0-2 * age:18-75 years * Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L * Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement) * Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) * Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study
Exclusion criteria
* Prior brain radiation therapy * Solitary brain metastasis according to Magnetic resonance imaging (MRI) * Mort than 3 extracranial organs have metastatic lesions * Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible). * pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| partial response rate of intracranial lesions | 2 years | Partial response rate of intracranial lesions will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 4 years | Progression-free survival will be evaluated |
| overall survival | 4 years | Overall survival will be evaluated |
| partial response rate of extracranial lesions | 2 years | Partial response rate of extracranial lesions will be evaluated |
| Health-related quality of life | 2 years | Health-related quality of life will be measured |
| safety and tolerability | 4 year | Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects |
| the relationship between Progression-Free Survival and EGFR mutation status | 4 years | The relationship between Progression-Free Survival and EGFR mutation status will be evaluated. |
Countries
China
Outcome results
None listed