A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 137
- 主要终点
- Percentage of margin-free resections produced by each program
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 before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.
详细描述
OBJECTIVES:
- Compare the percentage of margin-free resections in patients with locally advanced, potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and fluorouracil.
- Compare the efficacy of these regimens, as measured by CT scan response, in these patients.
- Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the duration of objective response in patients treated with these regimens.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.
Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
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 confirmed adenocarcinoma of the pancreas
- •No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms
- •Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons
- •Primary cancer in the head, body, or tail of pancreas
- •Measurable disease
- •No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis
- •No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count greater than 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor)
- •Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy
- •Creatinine less than 1.7 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •No other malignancy within the past 3 years except nonmelanoma skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for this disease
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to pancreas
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Percentage of margin-free resections produced by each program
次要结局
- Efficacy as measured by CT scan response
- Post-treatment fibrosis in the resected specimens
- Toxicity
- Duration of objective response
- Disease-free survival
- Overall survival
- Effect of therapy and recurrence on CA19-9 values