Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer

• Conditions: Circulating Tumor Cells

• Registration Number: NCT01052818
• Lead Sponsor: National Institute of Cancerología

Brief Summary

The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

Detailed Description

In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-08
• Status Verified: 2010-01
• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-18
• Last Update Submitted: 2010-01-18
• Study First Posted: 2010-01-20
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Histopathologic diagnosis of non small-cell lung cancer
• Clinical stage IV
• ECOG functional status 0 or 1
• No renal function alteration (GFR >50%)
• No hepatic function alteration (ALT and AST less than 2 times its normal value)
• Leucocytes more than 2,000/mcl
• Hemoglobin more than 10mg/dL
• Platelets more than 100,000/mcl

Exclusion Criteria

Non-advanced disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate, progression-free survival and over-all survival	4 years

Secondary Outcome Measures

Name	Time	Method
Quantification of CTCs	4 years

Trial Locations

Locations (1)

National Institute of Cancerologia; 🇲🇽 Mexico City, Distrito Federal, Mexico