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

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

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

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Li Zhang, M.D.; Email: zhangli6@mail.sysu.edu.cn
      • Principal Investigator: Li Zhang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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, who will receive routine first or second line chemotherapy, or EGFR-TKI for those with EGFR sensitive mutant type.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Treatment; Treatment: Chemotherapy or targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline CTC count	Two year

Secondary Outcome Measures

Outcome Measure	Time Frame
CTC count change	Two years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Cyttel Biosciences Inc.
• Investigators: Principal Investigator: Li Zhang, M.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Estimate): April 23, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: NSCLCCTC-SUMS01