Back to resultsRandom Trial for Elderly Patients With NSCLC
Primary Purpose
Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
vinorelbine, gemcitabine and carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
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)
Sites / Locations
- Inje University Sanggyepaik HospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00265694
Brief Title
Random Trial for Elderly Patients With NSCLC
Official Title
A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Inje University
4. Oversight
5. Study Description
Brief Summary
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.
The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague.
Gemcitabine and carboplatin have favorable toxicity profile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vinorelbine, gemcitabine and carboplatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Jin Yuh, M.D.
Phone
82-2-950-1460
Email
yjyuh@sanggyepaik.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Jin Yuh, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Sanggyepaik Hospital
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Jin Yuh, M.D.
Phone
82-2-950-1460
Email
yjyuh@sanggyepaik.ac.kr
First Name & Middle Initial & Last Name & Degree
Young Jin Yuh, M.D.
12. IPD Sharing Statement
Learn more about this trial
Random Trial for Elderly Patients With NSCLC
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