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Taking people in ItalyNo phase

Tests radiation before surgery for soft tissue sarcoma

Tests radiation given before surgery in adults with soft tissue sarcoma.

Plain-language title generated from the registry record
Registry title: Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Key facts

Where
Florence, ItalySee the site

Where in Italy

  • AOU CareggiFlorence, ItalyTaking people

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Trial details

Who runs it
Azienda Ospedaliero-Universitaria Careggi
Trial code
NCT05761054
Record updated
9 March 2023
Original description
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 (2GyRead full original descriptionShow less

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT05761054