A Prospective, Randomized Trial of Extended Lymphadenectomy in the Management of Resectable Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Surgery to remove the pancreas, some of the small intestine, and lymph nodes may be more effective treatment for cancer of the pancreas than surgery to remove the pancreas and some of the small intestine alone. 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. Combining surgery, radiation therapy, and chemotherapy may be an effective treatment for cancer of the pancreas.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the pancreas and a portion of the small intestine with or without removing lymph nodes, followed by radiation therapy and chemotherapy, in treating patients with cancer of the pancreas.
详细描述
OBJECTIVES:
- Assess the overall survival of patients with resectable ductal pancreatic adenocarcinoma undergoing extended versus standard pancreatoduodenectomy.
OUTLINE: Patients are randomized to undergo standard pancreatoduodenectomy (PD) or PD with extended lymph node resection after an exploratory laparotomy.
Patients receive adjuvant chemoradiation therapy 4-6 weeks after surgery, if no metastases are evident. Radiation therapy is given every week for 5 weeks. Fluorouracil/leucovorin calcium is administered by rapid IV push daily within 2 hours of radiation on days 1-4 of week 1 and days 29-31 of week 5.
Patients are followed every 4 months for the first year, then every 6 months for the next 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer
- •Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm
- •No evidence of extranodal metastatic disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3500/mm^3
- •Platelet count at least 100,000/mm^3
- •Not specified
- •Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR
- •Greater than 2/3 of one functioning kidney must be shielded during radiation therapy
- •Must have adequate oral nutrition (greater than 1200 calories daily)
- •Greater than 5 years since prior malignancy except:
- •Squamous cell skin cancer
- •Basal cell skin cancer
- •In situ cervical cancer
- •Not pregnant or lactating
- •Patients of reproductive potential must use effective birth control
- •No cystic neoplasms of the pancreas
- •No islet cell, periampullary or cholangiocarcinoma
- •No Federal Medical Center inmates
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for this disease
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiation therapy for this disease
- •No prior radiation therapy to the abdomen
- •Celiotomy and standardized exploration for resectability required
排除标准
- 未提供