The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Phase 2
Completed
- Conditions
- THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01797913
- Lead Sponsor
- Fudan University
- Brief Summary
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine gemcitabine -
- Primary Outcome Measures
Name Time Method PFS from the first cycle of treatment (day one) to two month after the last cycle
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cancer hospital Fudan University
🇨🇳Shanghai, Shanghai, China