Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01514877|
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : July 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic Cancer||Drug: Icotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer|
|Study Start Date :||January 2012|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
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.
- partial response rate of intracranial lesions [ Time Frame: 2 years ]Partial response rate of intracranial lesions will be measured.
- Progression-free survival [ Time Frame: 4 years ]Progression-free survival will be evaluated
- overall survival [ Time Frame: 4 years ]Overall survival will be evaluated
- partial response rate of extracranial lesions [ Time Frame: 2 years ]Partial response rate of extracranial lesions will be evaluated
- Health-related quality of life [ Time Frame: 2 years ]Health-related quality of life will be measured
- safety and tolerability [ Time Frame: 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 [ Time Frame: 4 years ]The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514877
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China, 310022|
|Principal Investigator:||Yun Fan, MD||Zhejiang Cancer Hospital|