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Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma

27. maj 2026 opdateret af: Xie Lu, Peking University People's Hospital

An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

55

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Peking University People's Hospital, Beijing, Beijing 100044
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

  1. The subject or their legal representative signs the written informed consent prior to enrollment.
  2. Age <= 55 years old.
  3. 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.
  4. Deemed difficult to achieve a satisfactory surgical margin by 2 or more senior musculoskeletal oncologists.
  5. ECOG Performance Status: 0-1.
  6. Expected life expectancy >= 3 months.
  7. 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:

  1. No opportunity for surgical resection after neoadjuvant chemotherapy.
  2. Extensive metastasis with no indication for local surgical resection.
  3. Uncontrolled concurrent medical conditions.
  4. Prior radiotherapy to the surgical site during front-line treatment.
  5. History of other malignant tumors within the past 5 years.
  6. Inability to cooperate with preoperative neoadjuvant radiotherapy (e.g., due to psychiatric factors).
  7. Any condition that, in the investigator's judgment, might harm the patient or prevent compliance with study requirements.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Local Recurrence-Free Survival (LRFS)
Tidsramme: 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.
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
Tidsramme: Postoperative week 2.
Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria.
Postoperative week 2.
Surgical Margin Status
Tidsramme: 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.
At the time of pathological evaluation, typically within 7 to 14 days post-surgery.

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University People's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PKUPH-sarcoma 25

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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