Preoperative radiation therapy for soft tissue sarcoma
Official title: Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
Run by Azienda Ospedaliero-Universitaria Careggi · NCT05761054 · Data updated 2026-11-12
This study is testing a new type of radiation treatment before surgery to see if it can help people with soft tissue sarcoma have better outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Florence, Fi) |
| Status | Recruiting |
| Started | July 19, 2022 |
| Main results expected | July 1, 2025 |
| Study ends | July 1, 2027 |
| Registry record updated | March 9, 2023 |
| Trial ID | NCT05761054 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a confirmed diagnosis of soft tissue sarcoma who are eligible for conservative surgery.
✕Probably not a fit
Patients who have previously received radiation therapy at the same site or are candidates for surgical amputation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of neoadjuvant radiotherapy with a simultaneous integrated boost (SIB) for patients with soft tissue sarcoma (STS) who are candidates for surgical resection. The treatment involves administering radiation in 25 daily fractions, targeting both the tumor and areas at risk of micrometastatic spread. The primary goal is to evaluate the effectiveness of this approach in improving surgical outcomes, while secondary objectives include assessing treatment outcomes and potential toxicity. The study will enroll patients with newly diagnosed or locoregional recurrent STS.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and reduce the risk of cancer recurrence in patients with soft tissue sarcoma.
How similar studies have gone: While similar approaches have been explored, this specific method of using simultaneous integrated boost in neoadjuvant settings for STS is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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AOU Careggi
Florence, Fi, Italy Recruiting
Study contacts
- Principal investigator: lorenzo livi, Dr — AOU Careggi
- Study coordinator: Marta Pacinico
- Email: marta.pacinico@unifi.it
- Phone: 0557947192
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.