Clinical trial NCT01514877: Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Metastatic Cancer
Keywords: tumors metastatic to brain
non-small cell lung cancer
Icotinib
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: partial response rate of intracranial lesions
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 4 years
measure: overall survival
timeFrame: 4 years
measure: partial response rate of extracranial lesions
timeFrame: 2 years
measure: Health-related quality of life
timeFrame: 2 years
measure: safety and tolerability
timeFrame: 4 year
measure: the relationship between Progression-Free Survival and EGFR mutation status
timeFrame: 4 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Yun Fan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fan Y, Huang Z, Fang L, Miao L, Gong L, Yu H, Yang H, Lei T, Mao W. A phase II study of icotinib and whole-brain radiotherapy in Chinese patients with brain metastases from non-small cell lung cancer. Cancer Chemother Pharmacol. 2015 Sep;76(3):517-23. doi: 10.1007/s00280-015-2760-5. Epub 2015 Jul 7.