Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— BRAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724801
• Other study ID #: CTONG1201
• 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
• 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.

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non Small Cell Lung Cancer

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