Back to resultsThe Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Primary Purpose
THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Cancer hospital Fudan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gemcitabine
Arm Description
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01797913
Brief Title
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Official Title
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
5. Study Description
Brief Summary
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8
Primary Outcome Measure Information:
Title
PFS
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
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