Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer (BRAIN)
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ClinicalTrials.gov Identifier: NCT01724801 |
Recruitment Status :
Completed
First Posted : November 12, 2012
Last Update Posted : March 1, 2017
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Condition or disease | Intervention/treatment | Phase |
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Brain Metastasis Non Small Cell Lung Cancer | Radiation: whole brain radiation(WBI) Drug: Icotinib | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 176 participants |
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 |
Study Start Date : | October 14, 2012 |
Actual Primary Completion Date : | June 30, 2015 |
Actual Study Completion Date : | September 14, 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: icotinib
icotinib administered orally at a dose of 125 mg 3 times daily
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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
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Radiation: whole brain radiation(WBI)
WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles |
- iPFS [ Time Frame: 18 months ]intracranial progression-free survival
- 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)
- Toxicity [ Time Frame: 24months ]adverse events(according to CTC4.0)
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
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.
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
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 |
Study Director: | Jinji Yang, MD | Guangdong Provincial People's Hospital |
Responsible Party: | Guangdong Association of Clinical Trials |
ClinicalTrials.gov Identifier: | NCT01724801 |
Other Study ID Numbers: |
CTONG1201 |
First Posted: | November 12, 2012 Key Record Dates |
Last Update Posted: | March 1, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
EGFR mutant |
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 |