Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma

Официальное название

An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential Surgery for High-Risk Localized Ewing Sarcoma

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Local Recurrence-Free Survival (LRFS) [Срок оценки: 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 [Срок оценки: Postoperative week 2.]
• Surgical Margin Status [Срок оценки: At the time of pathological evaluation, typically within 7 to 14 days post-surgery.]

Вторичные конечные точки (3)

• Icidence of Adverse Events (Safety) [Срок оценки: From enrollment up to 30 days after the completion of all treatments.]
• Event-Free Survival (EFS) [Срок оценки: 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) [Срок оценки: From the date of surgery up to the date of death from any cause, assessed up to 5 years post-surgery.]

Критерии участия

Критерии включения

• 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: 0-1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking University People's Hospital, Beijing, Beijing 100044 — Пекин

Идентификаторы

NCT: NCT07620431 · PKUPH-sarcoma 25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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