進行性腎細胞癌におけるスニチニブとソラフェニブの逐次療法の比較
基本情報
- NCT ID
- NCT01481870
- ステータス
- 不明
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 120
- 治験依頼者名
- Yamagata University
概要
The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.
対象疾患
介入
依頼者(Sponsor)
実施施設 (1)
山形内科消化器科
Yamagata, Japan