CTRI/2016/08/007156招募中3 期
Phase III randomized trial of high dose chemoradiation and systemic chemotherapy vs systemic chemotherapy alone in patients with unresectable nonmetastatic cholangiocarcinoma.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 155
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
入选标准
- •ECOG 0 to 2
- •Tissue diagnosis of adenocarcinoma of the biliary tract Wherever tissue diagnosis is not feasible inspite of repeated attempts a multidisciplinary consensus on clinicoradiological diagnosis of cholangiocarcinoma CA 19.9 100mg per ml with a radiological evidence of malignant stricture should be made and patients consent should be available for treatment without tissue diagnosis
- •Unresectable disease as determined by hepatobiliary surgical team
- •No evidence of peritoneal or distant metastasis
- •No radiological evidence of paraaortic nodal disease
- •Child A or Child B score 7
- •Ability to tolerate radical treatment
排除标准
- •Multicentric intrahepatic cholangiocarcinoma however adjacent satellite lesions are permitted
- •Inability to deliver safe radiation due to high tumor/ liver ratio
- •Active cholangitis
- •Expected Survival less than 6 months
- •Unresolved biliary tract obstruction
- •Inability in deliver systemic chemotherapy persistent bilirubin more than 3
研究者
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