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高齢肺がん患者に対するゲムシタビンとカルボプラチンの併用療法

基本情報

NCT ID
NCT00881296
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
60
治験依頼者名
Hamamatsu University

概要

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.

対象疾患

Non-Small Cell Lung Cancer

介入

gemcitabine and carboplatin(DRUG)
Gemcitabine(DRUG)

依頼者(Sponsor)

実施施設 (1)

浜松医科大学医学部附属病院

Hamamatsu, Shizuoka, Japan