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Clinical Trials in Italy / NCT05761054
Recruiting Not applicable

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

NCT05761054 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliero-Universitaria Careggi
Phase
Not applicable
Started
2022-07-19
Last updated
2023-03-09

Condition(s) studied

Soft Tissue Sarcoma

Investigational drug(s) / intervention(s)

RT

RT: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
AOU Careggi Florence Fi Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05761054 on ClinicalTrials.gov ↗ ← All trials in Italy