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Trial Title:
Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)
NCT ID:
NCT05761054
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
soft tissue sarcoma (STS)
Intensity Modulated Radiotherapy (IMRT)
boost
radiotherapy
locally advanced soft tissue sarcoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
RT
Description:
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.
Arm group label:
A
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.
Detailed description:
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. Objective: The primary objective is to evaluate the benefit
of radiotherapy with partial simultaneous integrated boost to the area at risk of
incomplete resection in the neoadjuvant treatment of soft tissue sarcoma candidate for
conservative surgery. The secondary objectives are to evaluate the outcomes and toxicity
Study population: Patients with de novo or locoregional recurrence of STS after surgery.
Estimated enrollment: 33 Inclusion criteria: STS candidate for surgical resection; age >
18 years Exclusion criteria: previous radiotherapy over the region of interests,
inability to express informed consent; planned amputation. Study arm: Intensity Modulated
Radiotherapy Study duration: 2 years Enrollment period: 3 years Global study duration: 5
years Current primary outcomes measures: Oncologically negative resection rate (R0 rate)
Current secondary outcomes measures: Pathologic Complete Response rate (pCR); Overall
Survival (OS); Disease Specific Survival (DSS) Local-Relapse Free Survival (LRFS);
Distant-Metastases-Free Survival (DMFS); incidence of acute and late toxicity according
to CTCAE v5.0 classification
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AOU Careggi
Address:
City:
Florence
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
lorenzo livi
Phone:
0557947192
Email:
marta.pacinico@unifi.it
Contact backup:
Last name:
Marta Pacinico
Phone:
0557947192
Start date:
July 19, 2022
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Azienda Ospedaliero-Universitaria Careggi
Agency class:
Other
Source:
Azienda Ospedaliero-Universitaria Careggi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761054
