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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797913
• Other study ID #: GEM-CJH
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2013
• Last updated: February 22, 2016
• Start date: August 2008

Study information

• Verified date: February 2016
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• gemcitabine
gemcitabine,1000mg/m2,ivgtt,DAY1&DAY8

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS		from the first cycle of treatment (day one) to two month after the last cycle	No