NCT00664911已完成4 期
Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour
GERCOR - Multidisciplinary Oncology Cooperative Group58 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 516
- 试验地点
- 58
- 主要终点
- Number of patients receiving therapeutic dose-intensive therapy (doses must be at least equivalent to two-thirds the dose that is usually administered according to AMM recommendations)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.
详细描述
OBJECTIVES:
Primary
- To determine a prognostic scale of the feasibility of chemotherapy (at least two-thirds of the dose intensity usually administered) in patients aged 75 years or older with solid tumour.
Secondary
- To evaluate the efficacy, in terms of clinical and/or biological response, of treatments administered.
- To evaluate the incidence of severe (grade 3-4) toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumour regardless of localization or stage
- •PATIENT CHARACTERISTICS:
- •> or = 75 years
- •patient planned to receive > or = 2/3 of standard dose of the first cycle
- •PRIOR CONCURRENT THERAPY:
- •Chemonaive patient.
排除标准
- 未提供
结局指标
主要结局
Number of patients receiving therapeutic dose-intensive therapy (doses must be at least equivalent to two-thirds the dose that is usually administered according to AMM recommendations)
时间窗: 3 months
dose reduction \< 33%
chemotherapy feasibility
时间窗: from inclusion to 3 months
ability to deliver at least 3 months of the planned regimen therapy.
次要结局
- Grade 3-4 toxicities according to NCI-CTCAE version 3(from inclusion to 3 months)
研究者
研究点 (58)
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