THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Conditions
Brief summary
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer
Interventions
DRUGgemcitabine
gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
18\ 75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy. 3\ 8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes Normal laboratory values: * leucocyte ≥ 4×109/L * neutrophil ≥ 1.5×109/L * platelet ≥ 100×109/L * Hemoglobin ≥ 10g/L * ALT and * AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent
Exclusion criteria
* Patients have used drugs according to protocol * Uncontrolled infection of Bacterial or virus or fungal * Patients with other malignant tumor * Uncontrolled brain metastases * Female patients during their pregnant and lactation period, or patients without contracep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | from the first cycle of treatment (day one) to two month after the last cycle |
Countries
China
Outcome results
None listed