NCT00275119Unknown2 期
Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables
GERCOR - Multidisciplinary Oncology Cooperative Group22 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
- 2 期
- 发起方
- 试验地点
- 22
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, 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 chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin.
Secondary
- Determine the tolerability of this regimen, in both the short- and long-term, in these patients.
- Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefits of this regimen in these patients.
- Determine locoregional and metastatic progression-free survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
- •Locally advanced, nonresectable disease
- •Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery
- •No visceral or peritoneal metastases
- •No adenocarcinoma of the bile ducts or the ampulla of Vater
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Stable or controlled pain with analgesics
- •Not pregnant or nursing
- •Neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.5 times normal OR < 3 mg/dL
- •Creatinine clearance ≥ 40 mL/min
- •Bilirubin ≤ 1.5 times normal
- •Alkaline phosphatase < 5 times normal
- •No medical condition that would preclude study treatment
- •No active infection
- •Negative pregnancy test
- •No serious cardiac or respiratory disease
- •No uncontrolled or persistent hypercalcemia
- •No pre-existing neuropathy
- •No biliary or gastro-duodenal obstruction
- •No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder
- •No familial, social, geographical, or psychological condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)
- •At least 2 months since prior radiotherapy
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Response rate
- Quality of life
- Recurrence-free survival
- Overall survival
- Tolerability
- Clinical benefits
- Locoregional and metastatic progression-free survival
研究者
研究点 (22)
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