Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

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

Identifiers

NCT: NCT07620431 · PKUPH-sarcoma 25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗