Clinical trial NCT02155426: Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With Chemotherapy and Targeted Therapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Cyttel Biosciences Inc.
First posted: 2014-06-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline CTC count
timeFrame: Two year
Secondary outcomes:
measure: CTC count change
timeFrame: Two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: