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Icotinib Treat the Patient With Brain Metastasis Epidermal Growth Factor Receptor(EGFR) Mutant Non Small Cell Lung Cancer Comparing With Whole Brain Radiotherapy (BRAIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Guangdong Association of Clinical Trials
Guangdong General Hospital
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials Identifier:
First received: October 14, 2012
Last updated: September 22, 2015
Last verified: September 2015
EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with EGFR-mutant non-small cell lung cancer.

Condition Intervention Phase
Brain Metastasis
Non Small Cell Lung Cancer
Radiation: whole brain radiation(WBI)
Drug: Icotinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Icotinib Treat the Patient With Brain Metastasis EGFR-mutant Non Small Cell Lung Cancer Comparing With Whole Brain Radiotherapy

Resource links provided by NLM:

Further study details as provided by Guangdong Association of Clinical Trials:

Primary Outcome Measures:
  • iPFS [ Time Frame: 18 months ]
    intracranial progression-free survival

Secondary Outcome Measures:
  • progress-free survival (PFS) [ Time Frame: up to 16 months ]
    progress-free survival

  • time of controlling brain metastasis symptom [ Time Frame: 18months ]
    time of controlling brain metastasis symptom

  • Response rate of brain metastasis [ Time Frame: 12months ]
    Response rate of brain metastasis

  • Cognitive function [ Time Frame: 18months ]
    Cognitive function

  • overall survival(OS) [ Time Frame: 24months ]
    overall survival(OS)

Other Outcome Measures:
  • Toxicity [ Time Frame: 24months ]
    adverse events(according to CTC4.0)

Estimated Enrollment: 170
Study Start Date: October 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: icotinib Drug: Icotinib
Icotinib 125mg tid
Active Comparator: Whole brain irradiation Radiation: whole brain radiation(WBI)
WBI : 30GY /10fractions/2weeks
No Intervention: NO

Detailed Description:
no available

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology.

Patient who brain metastases was shown in MRI or CT scan. Brain metastases lesions should be more than 3.The diameter among these lesions should be more than 1 centimeter.

Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group(ECOG) performance status 0-1. Life expectancy ≥12 weeks. The therapy of surgery,chemotherapy,radiotherapy that the patients were ever received should be more than 2 weeks ago.The patient had recovered from the treatment.

Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.

Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Written informed consent provided.

Exclusion Criteria:

Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.

Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.

Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.

Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .

Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.

Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.

Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )< 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment.

Patient need increase irradiation dose after routine irradiation(30GY/10f/2w) Patient should treat extra cranial lesions first. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01724801

Contact: Yisheng Huang, doctor 13719211288

China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yisheng Huang, Doctor    13719211288   
Principal Investigator: Yilong Wu, MD         
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Guangdong General Hospital
  More Information

Responsible Party: Guangdong Association of Clinical Trials Identifier: NCT01724801     History of Changes
Other Study ID Numbers: c-tong1201 
Study First Received: October 14, 2012
Last Updated: September 22, 2015

Keywords provided by Guangdong Association of Clinical Trials:
EGFR mutant

Additional relevant MeSH terms:
Carcinoma, Bronchogenic
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on February 23, 2017