Non-Small Cell Lung Cancer Clinical Trial
— GEEPOfficial title:
Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Verified date | May 2010 |
Source | Hamamatsu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Institutional Review Board |
Study type | Interventional |
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly
gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung
cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST
criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly
single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (>
76 years) who have received no prior treatment for non-small lung cancer. As secondary
objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin
combination chemotherapy, progression-free survival and overall survival will be evaluated
in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and
weekly single gemcitabine.
The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus
carboplatin may improve the efficacy.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 76 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Hamamatsu University School of Medicine | Hamamatsu | Shizuoka |
Lead Sponsor | Collaborator |
---|---|
Hamamatsu University |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy (response rate) | two-years, followed RECIST criteria | Yes | |
Secondary | The toxicity profile (adverse event profile) | two-years, followed NCI-CTCAE criteria | Yes |
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