NCT05224934招募中不适用
Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Peri-operative complications
研究概览
简要总结
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis
- •Sarcoma not originated from bone structure, abdominal or gynecological viscera
- •All disease can be included safely within one radiotherapy field
- •Absence of extension through the sciatic notch or across the diaphragm
- •Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma
- •ECOG performance status 0 to 2
- •American Society of Anesthesiologist (ASA) score ≤2
- •Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan
- •Normal bone marrow and hepatic function.
- •Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age
- •expected life expectancy longer than 5 years
- •Written consent form was given prior to treatment
- •Can safely be treated by radiotherapy and surgery
排除标准
- •metastatic disease
- •Tumor was previously treated by radiotherapy
- •Involvement of liver, pancreatic head or duodenum
结局指标
主要结局
Peri-operative complications
时间窗: From surgery date up to 7 days later
The proportion of patients who suffer from
次要结局
未报告次要终点
研究者
NINGNING LU
Principle Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (2)
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