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Trial Title:
Random Trial for Elderly Patients With NSCLC
NCT ID:
NCT00265694
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Gemcitabine
Vinorelbine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
vinorelbine, gemcitabine and carboplatin
Summary:
1. Recently a radomized trial of vinorelbine versus best supportive care in patients at
70 years of age or older demonstrated a definite improvement in overall survival
rate and quality of life with chemotherapy.
2. The role of combination therapy containing the platinum compound, which is the
standard therapy for the young patients is still vague.
3. Gemcitabine and carboplatin have favorable toxicity profile.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC
- No previous chemotherapy history
- Age ≥ 65 years
- ECOG performance status ≤ 2
- Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver
function (total bilirubin < 2.0 mg/dL, AST/ALT levels < 3 × the upper limit of
normal, serum creatinine < 2.0 mg/dL)
- Patients with informed written consent
Exclusion Criteria:
- Patients with other major illness(active infection, severe heart disease,
concomitant malignancy, etc)
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inje University Sanggyepaik Hospital
Address:
City:
Seoul
Zip:
139-707
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Young Jin Yuh, M.D.
Phone:
82-2-950-1460
Email:
yjyuh@sanggyepaik.ac.kr
Investigator:
Last name:
Young Jin Yuh, M.D.
Email:
Principal Investigator
Lead sponsor:
Agency:
Inje University
Agency class:
Other
Source:
Inje University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00265694
