Ewing SarcomaNCT07620431
Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma
An observational study of Ewing Sarcoma and Bone Neoplasms, run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Ewing Sarcoma, Bone Neoplasms
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Initial treated ewing sarcoma patients in PKUPH and later would recieve definitivesurgery in PKUPH with complete clinical materials.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital, Beijing, Beijing 100044
Beijing
Lu Xie, M.D., +8613401044719, xie.lu@hotmail.com
About this study
Official title: 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.
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.
- Conditions
- Ewing Sarcoma, Bone Neoplasms
- Keywords
- Neoadjuvant Radiotherapy, Preoperative Radiotherapy, Observational Study, Local Control Rate, Wound Healing
- Medical subject headings
- Sarcoma, Ewing, Bone Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence-Free Survival (LRFS)
Time from the date of surgery to the first documented local recurrence or death from any cause.
Measured: 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.
Measured: Postoperative week 2.
Surgical Margin Status
Pathological evaluation of margins (R0/R1/R2) and the distance to the closest margin.
Measured: At the time of pathological evaluation, typically within 7 to 14 days post-surgery.
Secondary outcomes (3)
Icidence of Adverse Events (Safety)
Grading and frequency of adverse events, particularly wound complications and infections, graded by CTCAE v5.0.
Measured: From enrollment up to 30 days after the completion of all treatments.
Event-Free Survival (EFS)
Time from surgery to disease progression, recurrence, or death from any cause.
Measured: 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 from surgery to death from any cause.
Measured: From the date of surgery up to the date of death from any cause, assessed up to 5 years post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620431
- Sponsor's protocol ID
- PKUPH-sarcoma 25
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential Surgery for High-Risk Localized Ewing Sarcoma
- ClinicalTrials.gov ID
- NCT07620431
- Acronym / sponsor ID
- PKUPH-sarcoma 25
- Conditions
- Ewing Sarcoma, Bone Neoplasms
- Keywords
- Neoadjuvant Radiotherapy, Preoperative Radiotherapy, Observational Study, Local Control Rate, Wound Healing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Initial treated ewing sarcoma patients in PKUPH and later would recieve definitivesurgery in PKUPH with complete clinical materials.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Wound Healing Status
Time frame: Postoperative week 2.
Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ewing Sarcoma and Bone Neoplasms, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Xie, M.D. (+8613401044719, xie.lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.