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NCT Number: NCT07620431

Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma

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.

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Key information

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time from the date of surgery to the first documented local recurrence or death from any cause.

  2. Wound Healing Status

    Time frame: Postoperative week 2.

    Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria.

  3. Surgical Margin Status

    Time frame: At the time of pathological evaluation, typically within 7 to 14 days post-surgery.

    Pathological evaluation of margins (R0/R1/R2) and the distance to the closest margin.

Secondary outcomes

  1. Icidence of Adverse Events (Safety)

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

    Grading and frequency of adverse events, particularly wound complications and infections, graded by CTCAE v5.0.

  2. 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.

    Time from surgery to disease progression, recurrence, or death from any cause.

  3. 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.

    Time from surgery to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Xie, M.D.

CONTACT

[email protected]

+8613401044719

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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