About this trial
This single-center prospective observational study aims to evaluate whether longitudinal changes in serum pro-gastrin-releasing peptide (ProGRP) reflect treatment response in patients with newly diagnosed Ewing sarcoma. Serum ProGRP levels will be measured before systemic treatment, during neoadjuvant chemotherapy, before local treatment, and after local treatment. Changes in ProGRP will be compared with radiographic tumor response assessed according to RECIST version 1.1. The study will also explore the ability of early ProGRP changes to predict objective radiographic response and the association between ProGRP patterns and event-free survival. ProGRP results obtained for research purposes will not be used to guide clinical treatment decisions.
Eligibility criteria
Qualifiers
Age 10 to 60 years.
Histologically confirmed Ewing sarcoma.
Newly diagnosed disease and scheduled to initiate first-line systemic therapy at Peking University People's Hospital.
No prior systemic chemotherapy for Ewing sarcoma and no prior radiotherapy to the primary tumor.
Disqualifiers
History of another malignant tumor within the previous 3 years, except for an adequately treated malignancy with a negligible risk of recurrence, as determined by the investigator.
New York Heart Association (NYHA) class III or IV heart failure.
Uncontrolled concomitant illness, including uncontrolled diabetes mellitus or an active infection.
Severe infection requiring intravenous antimicrobial treatment within 4 weeks before enrollment.
Trial design
Treatments tested in this trial
- Not listed