Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With Chemotherapy and Targeted Therapy

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With 1st or 2nd Line Line Chemotherapy and Targeted Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02155426
• Other study ID #: NSCLCCTC-SUMS01
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2014
• Last updated: April 22, 2015
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Sun Yat-sen University
• Contact: Li Zhang, M.D.
• Email: zhangli6[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy

BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.

PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of treatment (Overall response rate and Progression-free survival).

SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.

STUDY DESIGN : This is a prospective, observational study.

Duration of the inclusions: 12months.

SAMPLE SIZE : 1200 patients

Description:

This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy and targeted-therapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the treatment. Relationship between CTC count and clinical outcome will be analysed. The time points of blood drawing are set as following: for patients receiving chemotherapy, once prior to 1st cycle of chemotherapy, once 3 days prior to 2nd cycle of chemotherapy, posterior to 3th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD); for patients receiving targeted-therapy, once prior to treatment, once 1 month after treatment, and once when PD. The clinical outcome of treatment will be ultimately obtained.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable or combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.

• ECOG functional status=2

• Chemotherapy:According to routine 1st line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended. According to routine 2nd line chemotherapy in clinical practice,pemetrexed or docetaxol

• Targeted therapy:According to clinical criteria, patients with EGFR-TKI sensitive mutant accept first line TKI therapy.

• Patients must have measurable disease according to the RECIST (version 1.1) criteria

• Patients with a life expectancy greater than 12 weeks

• Written (signed) informed Consent to participate in the study

Exclusion Criteria:

• Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)

• Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.

• Unwilling to write informed consent to participate in the study

• Patients who is unwilling to accept the follow-up.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cyttel Biosciences Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline CTC count		Two year	No
Secondary	CTC count change		Two years	No