Adjuvant Versus Neo-adjuvant Radiotherapy in Patients With Resectable Soft Tissue Sarcoma in Extremities : Wound Complications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- wound and local complications
研究概览
简要总结
Extremity soft tissue sarcomas (ESTS)s are rare mesenchymal cancers that considered a challenge for orthopaedic surgeons. Soft tissue sarcomas (STS) comprise less than 1% of malignant cancers, commonly occur in the proximal extremities and trunk. Limb-sparing surgery mostly are targeted in most of the patients, so adjuvant or neoadjuvant radiotherapy is usually added. Preoperative radiotherapy (neoadjuvant) or postoperative radiotherapy (adjuvant) offers local control and survival rates, but the local complications are controversial. However, different retrospective studies had shown that preoperative radiotherapy cause higher wound complication rate, while both preoperative and postoperative radiotherapy had the same results regarding local recurrence
详细描述
Study Tools :The patients will be managed as follows:
Primary (Preoperative) Diagnosis and Evaluation
Clinical Evaluation. History. General examination. Local examination.
Radiological Evaluation:
Plain X-ray for the affected limb to determine presence of any bone affection or invasion.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex: both sexes.
- •Lesion: any soft tissue sarcoma in upper or lower limbs (synovial sarcoma, liposarcoma, fibrosarcoma and others)
- •age more than 16 years old
排除标准
- •Irresectable ESTS
- •Round cell ESTS
- •recurrent ESTS
- •patients who received local irradiation due to other causes
研究组 & 干预措施
preoperative radiotherapy
The patients which will receive preoperative radiotherapy
干预措施: surgical resection with safety margin (Procedure)
postoperative radiotherapy
The patients which will receive postoperative radiotherapy
干预措施: surgical resection with safety margin (Procedure)
结局指标
主要结局
wound and local complications
时间窗: 12 months
次要结局
- recurrence rate(2 years)
研究者
Ziad Khaled Abdullah Abdul Qader
orthopedic oncology department assistant lecturer
Ain Shams University