Study Of Post-Operative Concomitant Radio-Chemotherapy With A Continuous Infusion Of Flourouracil For Adjuvant Treatment Of Resected Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 58
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells left after surgery.
PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and radiation therapy in treating patients who have undergone surgery for pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the tolerance of adjuvant fluorouracil with concurrent radiotherapy in patients with resected pancreatic adenocarcinoma.
- Determine survival without local relapse in these patients treated with this regimen.
- Determine overall survival of these patients treated with this regimen.
- Determine the effectiveness of this adjuvant therapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive high-dose radiotherapy 5 days a week for 5 weeks. Patients also receive low-dose radiotherapy 4 times a week during the last 2 weeks of the 5-week course of treatment. Patients concurrently receive fluorouracil IV continuously for 5 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed pancreatic adenocarcinoma
- •Complete macroscopic resection of tumor within past 30 days
- •No residual visceral or peritoneal metastasis
- •Involvement of Vater's ampulla or extrahepatic bile duct allowed
- •No vesicular or intrahepatic cholangiocarcinomas
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Alkaline phosphatase less than 3 times normal
- •Bilirubin less than 1.5 times normal
- •Creatinine less than 1.5 times normal
- •Cardiovascular:
- •No serious cardiac failure
- •No serious respiratory failure
- •No other untreatable malignant tumors
- •No serious psychological, familial, social, or geographical conditions that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for pancreatic adenocarcinoma
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for pancreatic adenocarcinoma
- •No prior radiotherapy in an anatomically proximal region to treatment area
- •See Disease Characteristics
排除标准
- 未提供