Bone Neoplasms, Ewing Sarcoma
Conditions
Keywords
Neoadjuvant Radiotherapy, Preoperative Radiotherapy, Observational Study, Local Control Rate, Wound Healing
Brief 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.
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.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Recurrence-Free Survival (LRFS) | 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 | Postoperative week 2. | Evaluation of surgical wound healing grade (Grade A/B/C) according to clinical criteria. |
| Surgical Margin Status | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Icidence of Adverse Events (Safety) | 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. |
| Event-Free Survival (EFS) | 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. |
| Overall Survival (OS) | 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. |
Countries
China
Contacts
CONTACTLu Xie, M.D.
Outcome results
None listed