Status:
COMPLETED
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Fudan University
Conditions:
THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01797913
Start Date
August 1 2008
Last Update
February 23 2016
Active Locations (1)
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1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032