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