Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment33 (estimated)
SponsorAzienda Ospedaliero-Universitaria Careggi
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Florence, Fi)
StatusRecruiting
StartedJuly 19, 2022
Main results expectedJuly 1, 2025
Study endsJuly 1, 2027
Registry record updatedMarch 9, 2023
Trial IDNCT05761054 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

  • AOU Careggi
    Florence, Fi, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.