ウラシル・テガフール（UFT）による術後補助化学療法と手術単独療法を比較した無作為化比較試験（NSAS-CC）

基本情報

NCT ID: NCT00152230
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 900
治験依頼者名: Taiho Pharmaceutical Co., Ltd.

概要

This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

対象疾患

Colorectal Cancer

介入

UFT (uracil, tegafur)(DRUG)

Surgery alone(PROCEDURE)

依頼者（Sponsor）

大鵬薬品工業株式会社(INDUSTRY)

実施施設 (1)

国立研究開発法人国立がん研究センター中央病院

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan