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.
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.
Study Type
OBSERVATIONAL
Enrollment
55
Peking University People's Hospital, Beijing, Beijing 100044
Beijing, China
Local Recurrence-Free Survival (LRFS)
Time from the date of surgery to the first documented local recurrence or death from any cause.
Time frame: From the date of surgery up to the date of first documented local recurrence or death from any cause, assessed up to 5 years post-surgery.
Wound Healing Status
Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria.
Time frame: Postoperative week 2.
Surgical Margin Status
Pathological evaluation of margins (R0/R1/R2) and the distance to the closest margin.
Time frame: At the time of pathological evaluation, typically within 7 to 14 days post-surgery.
Icidence of Adverse Events (Safety)
Grading and frequency of adverse events, particularly wound complications and infections, graded by CTCAE v5.0.
Time frame: From enrollment up to 30 days after the completion of all treatments.
Event-Free Survival (EFS)
Time from surgery to disease progression, recurrence, or death from any cause.
Time frame: From the date of surgery up to the date of first documented disease progression, recurrence, or death from any cause, assessed up to 5 years post-surgery.
Overall Survival (OS)
Time from surgery to death from any cause.
Time frame: From the date of surgery up to the date of death from any cause, assessed up to 5 years post-surgery.
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