Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

Asymptomatic Brain Metastases of Non Small Cell Lung Cancer Clinical Trial

— EABM  

Official title:

Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02250846
• Other study ID #: WHXH-027
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 22, 2014
• Last updated: September 25, 2014
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2014
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. at the age of 18 -70 years old, male or female

2. the non-small cell lung cancer diagnosed by histopathology

3. detected by ARMS to confirm that the EGFR sensitive mutant patients

4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)

5. have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs

6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy

7. PS:0 or 1

8. the expected survival time 3 months >

9. patients signed informed consent voluntarily

Exclusion Criteria:

1. 4 weeks before entering the group received operation or operation, the wound has not healed completely

2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine

3. 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

4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment

5. before entering the group 4 weeks participated in any study drug clinical trial

6. there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome

7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent

8. suffering from a mental illness, poor compliance

9. the researchers think that do not fit into the group of cases

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• EGFR-TKI
egfr-TKI treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial disease progression time		20 months	Yes