Peking University People's Hospital, Beijing, Beijing 100044
Beijing, China
NCT Number: NCT07620431
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.
Trial opening soon.
Get Notified12 month and older
All sexes
Observational
Beijing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Postoperative week 2.
Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Peking University People's Hospital
Other
An Observational Study on the Safety and Efficacy of Neoadjuvant Concurrent Chemoradiotherapy Sequential Surgery for High-Risk Localized Ewing Sarcoma
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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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