NCT00436267Unknown2 期
Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tumor response
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil.
- Determine hepatic and systemic toxicity of this regimen in these patients.
Secondary
- Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients.
研究设计
- 研究类型
- Interventional
- 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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed pancreatic cancer with liver metastases
- •Unresectable disease AND meets any of the following criteria:
- •Newly diagnosed disease
- •No prior treatment
- •Received prior treatment and progressed
- •Underwent prior pancreatectomy and progressed
- •Liver-only disease (receives selective internal radiotherapy only)
- •No known CNS metastases
- •No known diffuse peritoneal metastases
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 80-100%
- •Life expectancy > 3 months
- •WBC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin < 2 mg/dL (without extrahepatic biliary obstruction)
- •Albumin > 2 g/dL
- •Creatinine < 2 mg/dL
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior surgery, chemotherapy, and biologic therapy allowed
- •No prior external beam radiotherapy to liver or pancreatic bed
排除标准
- 未提供
结局指标
主要结局
Tumor response
Hepatic and systemic toxicity
次要结局
- Time to progression
- Survival
研究者
研究点 (1)
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