Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

NCT02250846 | Unknown Phase 2

• 1 other identifier: WHXH-027
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.

Conditions

Asymptomatic Brain Metastases of Non Small Cell Lung Cancer

Keywords

EGFR mutations; asymptomatic brain metastases; EGFR-TKI; Erlotinib

Outcome Measures

Primary Outcomes (1)

• Intracranial disease progression time

  20 months

Study Arms (2)

arm a

EXPERIMENTAL

EGFR exon 19 mutation with EGFR-TKI

Drug: EGFR-TKI

arm b

EXPERIMENTAL

EGFR exon 21 mutation with EGFR-TKI

Drug: EGFR-TKI

Interventions

EGFR-TKI DRUG

egfr-TKI treatment

arm a; arm b

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at the age of 18 -70 years old, male or female
• the non-small cell lung cancer diagnosed by histopathology
• detected by ARMS to confirm that the EGFR sensitive mutant patients
• the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
• have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
• no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
• PS:0 or 1
• the expected survival time 3 months \>
• patients signed informed consent voluntarily

You may not qualify if:

• weeks before entering the group received operation or operation, the wound has not healed completely
• into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
• serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
• serious infection, need intravenous antibiotic, antifungal or antiviral treatment
• before entering the group 4 weeks participated in any study drug clinical trial
• there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
• the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
• suffering from a mental illness, poor compliance
• the researchers think that do not fit into the group of cases

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cancer center

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 26, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: September 26, 2014

Record last verified: 2014-09