Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Phase 2
76 Years
N/A
76 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Inclusion Criteria:
- Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
- Good performance status (ECOG 0-1)
- No previous treatment
- Age 76 years and older
- Adequate bone marrow, liver and renal functions
- No pregnant
- Measurable disease, defined as at least one lesion whose longest diameter can be
accurately measured as >=1.0 cm by spiral CT scan
- Provided written informed consent
Exclusion Criteria:
- Severe complications or a concomitant malignancy
- Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine
kinase inhibitors
- Interstitial pneumonia or lung fibrosis
- Contraindicated gemcitabine or carboplatin
- Inappropriate patients for entry to this study, judged by the physicians
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy (response rate)
Outcome Time Frame:
two-years, followed RECIST criteria
Safety Issue:
Yes
Principal Investigator
Kingo Chida, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Hamamatsu University
Authority:
Japan: Institutional Review Board
Study ID:
Hamamatsu 20-34
NCT ID:
NCT00881296
Start Date:
March 2008
Completion Date:
June 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Elder Patients
- Non-Small Cell Lung Cancer
- Previously Untreated
- Advanced
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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