Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria Careggi

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RT

Treatment groups

33 Participants
are divided into 1 treatment group