Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma

NCT07620431 | Not Yet Recruiting

• 1 other identifier: PKUPH-sarcoma 25
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ewing Sarcoma; Bone Neoplasms

Keywords

Neoadjuvant Radiotherapy; Preoperative Radiotherapy; Observational Study; Local Control Rate; Wound Healing

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (3)

• Icidence of Adverse Events (Safety)

  From enrollment up to 30 days after the completion of all treatments.

• Event-Free Survival (EFS)

  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)

  From the date of surgery up to the date of death from any cause, assessed up to 5 years post-surgery.

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initial treated ewing sarcoma patients in PKUPH and later would recieve definitivesurgery in PKUPH with complete clinical materials.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital, Beijing, Beijing 100044

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue samples for histological and genetic confirmation (FET family gene rearrangement via FISH or NGS).

MeSH Terms

Conditions

Sarcoma, Ewing; Bone Neoplasms

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Lu Xie, M.D.

CONTACT

+8613401044719; xie.lu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)