Phase II Interstitial Colloidal 32P Integrated in The Treatment of Non-Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.
详细描述
OBJECTIVES:
- Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.
OUTLINE: Patients are stratified according to prior therapy (yes vs no).
Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas
- •Diameter no greater than 5 cm
- •Volume no greater than 66 mL
- •No ascites (with or without tumor cells)
- •No endoscopically proven tumor penetration of duodenum or stomach
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 9 g/dL (transfusion allowed)
- •No hepatic disease
- •At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
- •No vascular occlusion of portal system
- •Creatinine no greater than 1.5 mg/dL
- •BUN no greater than 25 mg/dL
- •No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract
- •No complete surgical resection
- •No splenectomy
排除标准
- 未提供
结局指标
主要结局
Response rate
Duration of remission
Survival
次要结局
- Patterns of failure