Preoperative radiation therapy for soft tissue sarcoma
Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Florence, Fi) |
| Trial ID | NCT05761054 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of soft tissue sarcoma who are eligible for conservative surgery.
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.
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 performed: While similar approaches have been explored, this specific method of using simultaneous integrated boost in neoadjuvant settings for STS is relatively novel.
Eligibility criteria
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 this trial is running
Florence, Fi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.