RecruitingNot ApplicableNCT05761054

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)


Sponsor

Azienda Ospedaliero-Universitaria Careggi

Enrollment

33 participants

Start Date

Jul 19, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called SPRINT) is evaluating a new radiation treatment approach for soft tissue sarcomas, where a boosted radiation dose is delivered to the most high-risk areas of the tumor at the same time as the regular dose — before surgery. This technique is called a simultaneous integrated boost. **You may be eligible if...** - You are 18 or older - You have been confirmed to have a soft tissue sarcoma (a rare cancer of connective tissues like fat, muscle, or nerve) - Your doctors plan to perform limb-sparing (conservative) surgery rather than amputation - Your overall health is reasonably good (performance status ≤1 by WHO or ≥70 by KPS scale) **You may NOT be eligible if...** - You have had radiation therapy to the same area before - Amputation is the only surgical option for you - You have a connective tissue disease (like scleroderma or lupus) that would worsen with radiation - You have a psychiatric condition preventing you from giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONRT

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.


Locations(1)

AOU Careggi

Florence, Fi, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05761054


Related Trials