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Not yet recruitingNCT07620431Updated Jun 2, 2026

Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma

An observational study in Ewing Sarcoma and Bone Neoplasms, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Peking University People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
12 Months and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ewing Sarcoma
  • Bone Neoplasms

Keywords

  • Neoadjuvant Radiotherapy
  • Preoperative Radiotherapy
  • Observational Study
  • Local Control Rate
  • Wound Healing
03

In context

Sarcoma, Ewing

250 studies on the registry are indexed under Sarcoma, Ewing; 69 are open to participants now.

This study's planned enrollment of 55 is below the median of 124 across 35 observational studies indexed under Sarcoma, Ewing.

Browse Sarcoma, Ewing studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject or their legal representative signs the written prior to enrollment.
  2. Age \<= 55 years old.
  3. 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. Performance Status: 0-1.
  6. Expected >= 3 months.
  7. Women of must have a negative pregnancy test within 1 week prior to enrollment and agree to use ; male subjects must agree to use contraception or have undergone surgical sterilization during the study.

Exclusion criteria

Exclusion Criteria:

  1. No opportunity for surgical resection after chemotherapy.
  2. Extensive 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Local Recurrence-Free Survival (LRFS)

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

    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.

  2. Wound Healing Status

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

    Time frame: Postoperative week 2.

  3. Surgical Margin Status

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

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

Secondary outcomes

  1. Icidence of Adverse Events (Safety)

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

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

  2. Event-Free Survival (EFS)

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

    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.

  3. Overall Survival (OS)

    Time from surgery to death from any cause.

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

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Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07620431
Responsible party
Xie Lu (Principal Investigator, Peking University People's Hospital) — Principal investigator
First posted
Jun 2, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jun 2, 2026

Study contacts

Lu Xie, M.D.
Contact
xie.lu@hotmail.com
+8613401044719

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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