Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
SPRINT
1 other identifier
interventional
33
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2022
CompletedFirst Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedMarch 9, 2023
February 1, 2023
3 years
February 13, 2023
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
R0 rate
Oncologically negative resection rate
immediately after surgery
Secondary Outcomes (2)
(pCR);
immediately after surgery
(OS);
through study completion, average of 36 months
Study Arms (1)
A
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU Careggi
Florence, Fi, 50134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
lorenzo livi, Dr
AOU Careggi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 13, 2023
First Posted
March 9, 2023
Study Start
July 19, 2022
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2027
Last Updated
March 9, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share