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 October 2012 by Guangdong Association of Clinical Trials
Sponsor:
Collaborator:
Guangdong General Hospital
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier:
NCT01724801
First received: October 14, 2012
Last updated: November 7, 2012
Last verified: October 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    intracranial progression-free survival


Secondary Outcome Measures:
  • progress-free survival (PFS) [ Time Frame: up to 16 months ] [ Designated as safety issue: No ]
    progress-free survival

  • time of controlling brain metastasis symptom [ Time Frame: 18months ] [ Designated as safety issue: No ]
    time of controlling brain metastasis symptom

  • Response rate of brain metastasis [ Time Frame: 12months ] [ Designated as safety issue: No ]
    Response rate of brain metastasis

  • Cognitive function [ Time Frame: 18months ] [ Designated as safety issue: Yes ]
    Cognitive function

  • overall survival(OS) [ Time Frame: 24months ] [ Designated as safety issue: No ]
    overall survival(OS)


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


Estimated Enrollment: 170
Study Start Date: October 2012
Estimated Primary Completion Date: October 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01724801

Contacts
Contact: Yisheng Huang, doctor 13719211288 hysd999@hotmail.com

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Yisheng Huang, Doctor    13719211288    hysd999@hotmail.com   
Principal Investigator: Yilong Wu, MD         
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT01724801     History of Changes
Other Study ID Numbers: c-tong1201
Study First Received: October 14, 2012
Last Updated: November 7, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Guangdong Association of Clinical Trials:
EGFR mutant

Additional relevant MeSH terms:
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014