Dynamic Circulating Tumor Cell (CTC) Changes During the Chemotherapy in NSCLC (POLICE)

December 2, 2016 updated by: Guangdong Association of Clinical Trials

A Prospective Observational Study on the Dynamic Changes of CTC Enumeration in Advanced NSCLC With 1st Line Chemotherapy

Primary endpoint To observe the dynamic changes of CTC during the process of platinum based chemotherapy in advanced NSCLC.

To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and PFS).

Secondary endpoint To study the relationship between CTC and overall survival. To study the molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the first line chemotherapy. Analyze the relationship between CTC count and clinical outcome. The time points of blood drawing are set as following: once prior to 1st cycle of chemotherapy, once 1 week prior to 2nd cycle of chemotherapy, posterior to 4th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD). The specific blood tube CellSave Tube will be used, 7.5ml blood sample every time. One follow-up (including by phone) be made every 3 month after PD until death. The clinical outcome of first line chemotherapy will be ultimately obtained.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced NSCLC (stage IIIb/IV or recurrent NSCLC)

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 performance status of ≤ 2.
  • Patients without prior chemotherapy or therapy with systemic anti-neoplastic therapy. Previous adjuvant or neo-adjuvant treatment or combine chemoradiotherapy for stage I to III is permitted if completed > 12 months before enrollment.
  • According to routine first line doublet chemotherapy in clinical practice, Cisplatin or carboplatin combined with gemcitabine or paclitaxel or docetaxol or Vinorelbine were recommended.
  • Patients must have measurable disease according to the RECIST (version 1.1) criteria.
  • Life expectancy of at least 12 weeks.
  • Age ≥ 18 years.
  • Written (signed) informed Consent to participate in the study.
  • Adequate organ function as defined by the following criteria:Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl. Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).
  • For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:

  • Patients with prior chemotherapy or therapy with systemic anti-cancer therapy including target therapy. Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
  • 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 have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
  • Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
  • Nursing or lactating women.
  • Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
  • Unwilling to write informed consent to participate in the study.
  • Patients who is unwilling to accept the follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dynamic CTC changes during chemotherapy
Time Frame: baseline, 3 weeks and up to progression disease of chemotherapy
baseline, 3 weeks and up to progression disease of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Association of Clinical Trials

Investigators

  • Principal Investigator: Yi-Long Wu, MD, Guangdong General Hospital & Guangdong Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTONG1202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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