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临床试验/NCT00691691
NCT00691691Unknown2 期

A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Alberta Health services2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
2 期
入组人数
71
试验地点
2
主要终点
Response rate to SBRT

研究概览

简要总结

Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically conformation of liver malignancy
  • Solitary or multiple liver tumors amenable to SBRT
  • No jaundice or liver dysfunction
  • For metastases, the primary tumor site has been adequately treated.
  • For primary hepatoma, no extra-hepatic disease
  • Karnofsky > 70

排除标准

  • no extra-hepatic disease
  • Liver failure or inadequate liver function
  • Previous radiation therapy to the liver
  • lesions invading major blood vessels in the porta region
  • Contraindication to receive radiation therapy in the liver

结局指标

主要结局

Response rate to SBRT

时间窗: 3-6 Months

次要结局

  • Treatment Related Toxicity(12 months)

研究者

申办方类型
Other

研究点 (2)

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