NCT05761054Recruiting
Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
Source: ClinicalTrials.gov · Last updated 9 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 13 Feb 2023
- Start date
- 19 Jul 2022
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Diseases
- Sarcoma
- NCT number
- NCT05761054
What you commit to
- Study type: Interventional
- Planned participants: 33
- From 19 Jul 2022 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy at the same site
- Candidate for Surgical Amputation
Other illness
- Patients with comorbidities for collagen diseases
- Psychiatric disorders that may preclude obtaining the informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AOU Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.