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Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01514877
First received: January 17, 2012
Last updated: July 22, 2014
Last verified: July 2014

January 17, 2012
July 22, 2014
January 2012
July 2014   (final data collection date for primary outcome measure)
partial response rate of intracranial lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Partial response rate of intracranial lesions will be measured.
Same as current
Complete list of historical versions of study NCT01514877 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer
Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Cancer
  • Metastatic Cancer
Drug: 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.
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.
Intervention: Drug: Icotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01514877
ZhejiangCH-LCBM-1201
Yes
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
Not Provided
Principal Investigator: Yun Fan, MD Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP