NCT05761054 Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
| NCT ID | NCT05761054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2022-07-19 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2022-07-19 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Intervention prospective monocentric one arm study on the use of neoadjuvant radiotherapy with simultaneous integrated boost (Simultaneous Integrated Boost, SIB) in patients with STS with indication for preoperative radiotherapy. The treatment will be administered in 25 daily fractions (Monday-Friday) at the disease site to include the region of suspected micrometastatic spread (Clinical Target Volume 1, CTV1) at a dose of 50 Gy (2Gy / fraction) with SIB intensification on volume reduced corresponding to the interface sites between the tumor and the vascular / nerve axes (Clinical Target Volume 2, CTV2) at a dose of 60 Gy (2.4 Gy / fraction). The association with neoadjuvant chemotherapy based on anthracyclines is allowed.
Eligibility Criteria
Inclusion Criteria: * Patients aged ≥ 18 years * Confirmed histological diagnosis of soft tissue sarcoma * Candidate for conservative surgery * Performance status ≤ 1 according to WHO (or ≥ 70 according to KPS) before starting the treatment in the office. Exclusion Criteria: * Previous radiotherapy at the same site * Candidate for Surgical Amputation * Patients with comorbidities for collagen diseases * Psychiatric disorders that may preclude obtaining the informed consent
Contact & Investigator
lorenzo livi, Dr
PRINCIPAL INVESTIGATOR
AOU Careggi
Frequently Asked Questions
Who can join the NCT05761054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05761054 currently recruiting?
Yes, NCT05761054 is actively recruiting participants. Contact the research team at marta.pacinico@unifi.it for enrollment information.
Where is the NCT05761054 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT05761054 clinical trial?
NCT05761054 is sponsored by Azienda Ospedaliero-Universitaria Careggi. The principal investigator is lorenzo livi, Dr at AOU Careggi. The trial plans to enroll 33 participants.