An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential Surgery for High-Risk Localized Ewing Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
研究概览
简要总结
This is a single-center, single-arm, prospective observational study to evaluate the long-term local control rate, safety, and efficacy of preoperative neoadjuvant radiotherapy (36-45 Gy) followed by sequential radical surgery and postoperative chemotherapy in patients with high-risk, resectable localized Ewing sarcoma.
详细描述
Patients diagnosed with high-risk localized Ewing sarcoma will routinely receive standard neoadjuvant chemotherapy. For patients with resectable tumors, preoperative neoadjuvant radiotherapy at a dose of 36-45 Gy will be administered, followed by definitive surgery and subsequent adjuvant chemotherapy. This study does not interfere with standard clinical management and focuses on collecting follow-up data to observe the local recurrence-free survival (LRFS), wound complications, and surgical margin status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or their legal representative signs the written informed consent prior to enrollment.
- •Age <= 55 years old.
- •Histologically confirmed Ewing sarcoma, with FET family (including EWSR1 or FUS) gene rearrangement confirmed by FISH or NGS. Clear FET-non ETS fusion cases are excluded.
- •Deemed difficult to achieve a satisfactory surgical margin by 2 or more senior musculoskeletal oncologists.
- •ECOG Performance Status: 0-
- •Expected life expectancy >= 3 months.
- •Women of childbearing potential must have a negative pregnancy test within 1 week prior to enrollment and agree to use contraception; male subjects must agree to use contraception or have undergone surgical sterilization during the study.
排除标准
- •No opportunity for surgical resection after neoadjuvant chemotherapy.
- •Extensive metastasis with no indication for local surgical resection.
- •Uncontrolled concurrent medical conditions.
- •Prior radiotherapy to the surgical site during front-line treatment.
- •History of other malignant tumors within the past 5 years.
- •Inability to cooperate with preoperative neoadjuvant radiotherapy (e.g., due to psychiatric factors).
- •Any condition that, in the investigator's judgment, might harm the patient or prevent compliance with study requirements.
研究者
Xie Lu
Principal Investigator
Peking University People's Hospital