A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02803619

Enrollment

Registered

2016-06-17

Start date

2013-11-30

Completion date

Unknown

Last updated

2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptomeningeal Metastasis, Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer, leptomeningeal metastasis, EGFR sensitive mutations

Brief summary

Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. The cytological identification of malignant cells within cerebrospinal fluid (CSF). 2. Non-small cell lung cancer patients. 3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection. 4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture. 5. Expected survival time is greater than 1 month.

Exclusion criteria

Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

Design outcomes

Primary

Measure	Time frame
Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients	1 year

Countries

China

Contacts

Primary ContactMengzhao Wang, MD

mengzhaowang@sina.com010-69155039

Outcome results