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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Local Recurrence-Free Survival (LRFS) | Time from the date of surgery to the first documented local recurrence or death from any cause. | 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. | Postoperative week 2. |
| Surgical Margin Status | Pathological evaluation of margins (R0/R1/R2) and the distance to the closest margin. | At the time of pathological evaluation, typically within 7 to 14 days post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Icidence of Adverse Events (Safety) | Grading and frequency of adverse events, particularly wound complications and infections, graded by CTCAE v5.0. | From enrollment up to 30 days after the completion of all treatments. |
| Event-Free Survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Initial treated ewing sarcoma patients in PKUPH and later would recieve definitivesurgery in PKUPH with complete clinical materials.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Xie, M.D. | Contact | +8613401044719 | xie.lu@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital, Beijing, Beijing 100044 | Beijing | China |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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Tumor tissue samples for histological and genetic confirmation (FET family gene rearrangement via FISH or NGS).
Time from surgery to disease progression, recurrence, or death from any cause.
| 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. | From the date of surgery up to the date of death from any cause, assessed up to 5 years post-surgery. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |