NL-OMON44796已完成3 期
eo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases ;The CHARISMA randomized multicenter clinical trial - CHARISMA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age * 18 years.
- •* ECOG performance status 0 or 1
- •* Histologically confirmed primary colorectal carcinoma. Primary colorectal carcinomas to be included are:
- •* Previously resected histologically proven colorectal carcinoma
- •* Coloncarcinoma still in situ, deemed suitable for resection at the time of liver surgery
- •* Rectal carcinoma still in situ, requiring no neo-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
- •* Rectal carcinoma still in situ, requiring short-course neo-adjuvant radiotherapy, deemed suitable for resection at the time of liver surgery
- •* Radiologically confirmed and resectable liver metastasis of colorectal cancer after surgery. Criteria for resectability are outlined in the study protocol.
- •* Clinical risk score of 3-5
排除标准
- •* Prior adjuvant chemotherapy for the primary colorectal carcinoma given <6 months prior to detection of the liver metastases.
- •* Prior non colorectal malignancies, except for patients with basal or squamous cell carcinoma of the skin, or patients with carcinoma in situ of the cervix.
- •* Presence of extrahepatic disease
- •* Locally advanced rectal cancer in situ requiring long-course pre-operative chemoradiotherapy
- •* Major surgical procedure <4 weeks prior to randomization.
研究者
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