The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Fudan University

Status and phase: Completed; Phase 2

Conditions: THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Treatments: Drug: gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01797913

GEM-CJH

Details and patient eligibility

About

assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

gemcitabine

Experimental group

Treatment:

Drug: gemcitabine