NCT00075452Unknown3 期
Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
GERCOR - Multidisciplinary Oncology Cooperative Group76 个研究点 分布在 1 个国家开始时间: 2003年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 76
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.
PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.
Secondary
- Compare the time of response in patients treated with these regimens.
- Compare the clinical benefit of and tolerance to these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free survival of 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
- 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
- •Locally advanced or metastatic disease
- •Unresectable disease
- •Measurable disease
- •At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
- •No adenocarcinoma of the bile ducts or ampulla of Vater
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 1.5 times normal
- •Alkaline phosphatase less than 5 times normal
- •Creatinine less than 1.5 times normal
- •No uncontrolled or persistent hypercalcemia
- •Cardiovascular
- •No serious cardiac failure
- •No serious respiratory failure
- •Pain must be stabilized or controlled before initiation of study treatment
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other untreatable malignant tumor
- •No serious psychological, familial, social, or geographical condition that would preclude study participation
- •No neuropathy that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •No concurrent corticosteroids except for antiemetic therapy
- •Radiotherapy
- •No prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Quality of life
- Progression-free survival
- Time to response
- Clinical benefit
研究者
研究点 (76)
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