Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
Azienda Ospedaliero-Universitaria Careggi
33 participants
Jul 19, 2022
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
Inclusion Criteria4
- 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 Criteria4
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05761054