NCT00091351已完成3 期
A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 118
- 主要终点
- Progression-free survival at 5 years
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.
PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.
详细描述
OBJECTIVES:
Primary
- Compare progression-free survival of patients with primary soft tissue sarcoma of the retroperitoneum or pelvis treated with surgery with vs without preoperative radiotherapy.
Secondary
- Compare the toxicity and complications associated with these regimens in these patients.
- Compare the rate of microscopically complete surgical resection in patients treated with these regimens.
- Compare the overall survival rate of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Progression-free survival at 5 years
时间窗: at 5 years
次要结局
未报告次要终点
研究者
研究点 (118)
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