Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Recruiting now · Not applicable

Conditions studied: Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT05761054

Run by

Azienda Ospedaliero-Universitaria Careggi

People needed

33

Starts

2022-07-19

Expected to finish

2027-07-01

Last updated by the study team

2023-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• AOU Careggi — Florence, Fi, Italy (enrolling)

Full record on ClinicalTrials.gov

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