NCT00268333已完成2 期
Phase II Study of Recurrent Ganglionic Colorectal Cancer Not Accessible By Surgery Treated Using Chemotherapy With Simplified FOLFOX7 Followed By Radiotherapy Combined With 5FU and Oxaliplatin
GERCOR - Multidisciplinary Oncology Cooperative Group18 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2005年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 18
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin, 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.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with recurrent metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent metastatic colorectal cancer treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by radiotherapy and concurrent fluorouracil and oxaliplatin.
Secondary
- Determine the overall survival and disease-free survival of patients treated with this regimen.
- Determine the primary site of recurrence and time to recurrence in patients treated with this regimen.
- Determine quality of life of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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 colon or rectum
- •Metastatic disease isolated to the following lymph nodes:
- •Interaortic
- •Celiomesenteric
- •Retroperitoneal, including the following sites:
- •Peri-uretal
- •Mediastinum
- •Incompletely resected disease
- •Recurrent disease, defined by 1 of the following criteria:
- •Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin
- •Progressive disease after cisplatin or fluorouracil
- •Must be able to be encompassed in radiation field
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- •Life expectancy more than 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000 /mm^3
- •Alkaline phosphatase ≤ 5 times normal
- •Bilirubin ≤ 2 times normal
- •Creatinine < 2 times normal or creatinine clearance ≥ 40 mL/min
- •No peripheral neuropathy > grade 1
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No weight loss > 15% since diagnosis of recurrent disease
- •No uncontrolled heart disease
- •No angina
- •No symptomatic disease of the inferior artery
- •No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior chemotherapy or radiotherapy
- •No concurrent corticosteroids
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Overall survival
- Disease-free survival
- Primary site of recurrence
- Time to recurrence
- Quality of life
研究者
研究点 (18)
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