Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05761054

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Led by Azienda Ospedaliero-Universitaria Careggi · Updated on 2023-03-09

33

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 65 18 years
  • Confirmed histological diagnosis of soft tissue sarcoma
  • Candidate for conservative surgery
  • Performance status 64 1 according to WHO or 65 70 according to Karnofsky Performance Status before treatment start
Not Eligible

You will not qualify if you...

  • Previous radiotherapy at the same site
  • Candidate for surgical amputation
  • Comorbidities related to collagen diseases
  • Psychiatric disorders that may prevent informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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+1

Trial Site Locations

Total: 1 location

1

AOU Careggi

Florence, Fi, Italy, 50134

Actively Recruiting

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Research Team

M

Marta Pacinico

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT) | DecenTrialz