Lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of squamous cell carcinoma; 2. Advanced stage (M1a or M1b); Number of distant metastasis <3; 3. Patients received first-line GP/GC (gemcitabine plus cisplatin or carboplatin) chemotherapy, after 4 courses of treatment the efficacy is CR, PR or SD; 4. There must be measurable lesions according to the RECIST standards; 5. The imaging features must be central type with a location in the segment or above; 6. ECOG physical status score of 0-2; 7. With a life expectancy of 12 weeks; 8. Patients with good compliance and geographic proximity to ensure adequate follow-up; 9. Including the following adequate organ function: Bone marrow: absolute neutrophil count (ANC) = 1.5*10^9/L; 100*10^9/L = 9g/L. = platelet, hemoglobin Liver function: bilirubin is less than or equal to 1.5 times the normal value of the upper limit of normal (ULN); alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate amino shift enzyme (AST) is less than or equal to three times the ULN (such as liver metastasis, AP, ALT, AST is less than or equal to five times the ULN). Renal function: creatinine clearance rate was higher than 45mL/min (standard Cockcroft-Gault formula); 9. Male or female, aged 18 years or older; 10. Male and female with fertility must use effective contraception (e.g., intrauterine devices, oral contraceptives, or condoms); 11. Informed consent signed; 12. Asymptomatic brain metastasis without spinal cord compression; 13. Weight loss less than 10% in 6 months.
Exclusion criteria
Exclusion criteria: 1. With symptoms of cerebral metastasis or spinal cord compression, the number of metastatic more than 3; 2. Receive other anti-tumor therapy simultaneously; 3. With active infection; 4. according to the researcher's judgment, the patient can not complete the research safely; 5. Pregnant or breastfeeding; 6. Have obvious neurological or psychiatric history, including epilepsy or dementia; 7. Have other malignant tumor, basal cell carcinoma, or carcinoma of the cervix, except in situ of the tumor, within 5 years; 8. Uncontrollable pleural effusion and ascites; 9. Weight loss more than 10% in 6 months; 10. Disease progression after first-line chemotherapy; 11. Known to docetaxel and auxiliary agent allergy; 12. Receive more than 1 cycle of first-line chemotherapy drug therapy; 13. Once accepted chest radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall response rate;Duration of the respons;Safety;Quality of life; | — |
Countries
China