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Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer (BRAIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724801
First Posted: November 12, 2012
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Guangdong General Hospital
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials
  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
Intervention Model: Parallel Assignment
Masking: None (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)


Enrollment: 176
Study Start Date: October 14, 2012
Study Completion Date: September 14, 2016
Primary Completion Date: June 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: icotinib
icotinib administered orally at a dose of 125 mg 3 times daily
Drug: Icotinib
administered orally at a dose of 125 mg 3 times daily
Active Comparator: Whole brain irradiation
Whole brain irradiation 30Gy/3Gy/10 fractions plus concurrent or sequential chemotherapy for 4-6 cycles
Radiation: whole brain radiation(WBI)
WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles

Detailed Description:
no available
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724801


Locations
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Guangdong General Hospital
Investigators
Study Director: Jinji Yang, MD Guangdong General Hospital
  More Information

Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT01724801     History of Changes
Other Study ID Numbers: CTONG1201
First Submitted: October 14, 2012
First Posted: November 12, 2012
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Guangdong Association of Clinical Trials:
EGFR mutant

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