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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01724801
Other study ID # CTONG1201
Secondary ID
Status Completed
Phase Phase 3
First received October 14, 2012
Last updated February 28, 2017
Start date October 14, 2012
Est. completion date September 14, 2016

Study information

Verified date February 2017
Source Guangdong Association of Clinical Trials
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

no available


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date September 14, 2016
Est. primary completion date June 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Radiation:
whole brain radiation(WBI)
WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles
Drug:
Icotinib
administered orally at a dose of 125 mg 3 times daily

Locations

Country Name City State
China Guangdong General Hospital Guangzhou Guangdong
China Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangdong Association of Clinical Trials Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Toxicity adverse events(according to CTC4.0) 24months
Primary iPFS intracranial progression-free survival 18 months
Secondary progress-free survival (PFS) progress-free survival up to 16 months
Secondary time of controlling brain metastasis symptom time of controlling brain metastasis symptom 18months
Secondary Response rate of brain metastasis Response rate of brain metastasis 12months
Secondary Cognitive function Cognitive function 18months
Secondary overall survival(OS) overall survival(OS) 24months
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