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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Time Frame:

from the first cycle of treatment (day one) to two month after the last cycle

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

GEM-CJH

NCT ID:

NCT01797913

Start Date:

August 2008

Completion Date:

Related Keywords:

  • THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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