Non-squamous non-small cell lung cancer
Conditions
Interventions
Non-squamous non-small cell lung cancer:Folate receptor-positive cell detection kit
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent must be signed, patients agreed to perform peripheral blood FR-positive CTC test before the initiation of chemotherapy; 2. Aged between 18 and 75 years old; 3. Performance status (PS) 0-1 on the Eastern Cooperative Oncology Group (ECOG) Scale; 4. Histologically/cytologically confirmed stage IIIB/IV NSCLC; 5. Chemotherapy-na?ve for advanced disease; 6. Adequate organ function including the following: (1) Bone marrow: absolute neutrophil count (ANC) = 1.5 x 10^9/L, platelets = 100 x 10^9/L hemoglobin = 9 g/dL; (2) Hepatic: total bilirubin = 1.5 times the upper limit of normal (ULN), liver transaminases: aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) = 2.5 times ULN. AST and ALT = 5 x ULN may be included only if patient has liver metastasis; (3) Renal: calculated creatinine clearance = 45 mL/min (using the standard Cockcroft-Gault formula). 7. Estimated life expectancy of at least 8 weeks; 8. For women: must be surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 3 months after the treatment period; must not be pregnant and must not be lactating; negative pregnancy test is required for women of childbearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. For men: must be surgically sterile or compliant with a highly effective contraceptive method during and for 3 months after the treatment period; 9. Patient compliance and geographic proximity that allow adequate follow-up. 10. If blood samples were insufficient for CTC analysis due to presence of blood coagulation, sample volume less than 3 mL, or hemolysis, blood samples could be re-collected from those patients for sufficient samples to perform CTC analysis.
Exclusion criteria
Exclusion criteria: 1. Patient got disease relapsed within 12 months after post-operative adjuvant chemotherapy; 2. Advanced NSCLC with EGFR activating mutations; 3. History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis & T1]; 4. Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that will compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator; 5. Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone; 6. Inability to comply with protocol or study procedures; 7. Concurrent use of any other anti-tumor therapy during study; 8. Blood samples were not collected at the assigned time point; 9. Poor compliance, unable to obtain informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8-month PFS; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai Pulmonary Hospital
Outcome results
None listed