Spots Global Cancer Trial Database for Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer
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Trial Identification
Brief Title: Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer
Official Title: Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
Study ID: NCT00881296
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 76 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan
Contact Details
Name: Kingo Chida, MD,PhD
Affiliation: Hamamatsu University
Role: STUDY_CHAIR
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