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Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

RECRUITINGN/ASponsored by Azienda Ospedaliero-Universitaria Careggi
Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliero-Universitaria Careggi
Started2022-07-19
Est. completion2025-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05761054

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerSoft Tissue Sarcoma

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