NCT00416507已完成3 期
Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone
Federation Francophone de Cancerologie Digestive0 个研究点目标入组 190 人开始时间: 2000年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with nonresectable, nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil, cisplatin, and radiotherapy followed by gemcitabine hydrochloride.
Secondary
- Compare the toxicities of these regimens in these patients.
- Compare the objective response (complete, partial, or stable) in patients treated with these regimens.
- Compare the clinical benefit, in terms of general condition and weight maintenance in patients treated with these regimens.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •No neuroendocrine or other histologies
- •No extra-abdominal metastases
- •No hepatic or peritoneal metastases by celioscopy
- •Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed
- •Nonresectable disease meeting ≥ 1 of the following criteria:
- •Arterial invasion
- •Mesenteric-portal vein invasion > 15 mm and or less than hemicircumference
- •Satellite adenopathies encompassed in the radiation field
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Bilirubin < 1.75 mg/dL
- •Creatinine < 1.5 mg/dL
- •WBC > 1,500/mm³
- •Platelet count > 100,000/mm³
- •No major organ disorder, including cardiac or coronary insufficiency
- •Prothrombin time > 80%
- •No psychiatric or social condition that would preclude study therapy
- •No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No contraindications to radiotherapy or chemotherapy
- •No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy
- •PRIOR CONCURRENT THERAPY:
- •No prior adjuvant or palliative chemotherapy or radiotherapy
- •Prior surgical diversion of the biliary and/or digestive tract allowed
排除标准
- 未提供
研究者
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