Neoadjuvant Radiotherapy and Surgery for High-Risk Localized Ewing Sarcoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Initial treated ewing sarcoma patients in PKUPH and later would recieve definitivesurgery in PKUPH with complete clinical materials.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: