Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer|
- partial response rate of intracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]Partial response rate of intracranial lesions will be measured.
- Progression-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]Progression-free survival will be evaluated
- overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]Overall survival will be evaluated
- partial response rate of extracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]Partial response rate of extracranial lesions will be evaluated
- Health-related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Health-related quality of life will be measured
- safety and tolerability [ Time Frame: 4 year ] [ Designated as safety issue: Yes ]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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.
|Study Start Date:||January 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Icotinib plus Whole Brain Radiotherapy
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced non-small cell lung cancer (NSCLC) patients with brain metastases (BM). Icotinib is a new first generation EGFR-TKI. We conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with whole brain radiotherapy （WBRT） in Chinese NSCLC patients with BM and investigated the cerebrospinal fluid (CSF)/ plasma concentrations of icotinib.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514877
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China, 310022|
|Principal Investigator:||Yun Fan, MD||Zhejiang Cancer Hospital|