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NCT Number: NCT01514877

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.

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Key information

Conditions

Lung Cancer Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Icotinib

Drug

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.

Primary outcomes

  1. partial response rate of intracranial lesions

    Time frame: 2 years

    Partial response rate of intracranial lesions will be measured.

Secondary outcomes

  1. Progression-free survival

    Time frame: 4 years

    Progression-free survival will be evaluated

  2. overall survival

    Time frame: 4 years

    Overall survival will be evaluated

  3. partial response rate of extracranial lesions

    Time frame: 2 years

    Partial response rate of extracranial lesions will be evaluated

  4. Health-related quality of life

    Time frame: 2 years

    Health-related quality of life will be measured

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Phase II Study of Icotinib Combined With Whole Brain Radiotherapy in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2012
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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