Status:
COMPLETED
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01514877
Start Date
January 1 2012
End Date
July 1 2014
Last Update
July 23 2014
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022