Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Soft Tissue Sarcoma Clinical Trial

— SPRINT  

Official title:

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761054
• Other study ID #: SPRINT
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: February 2023
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Marta Pacinico
• Phone: 0557947192
• Email: marta.pacinico[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Radiation:
• RT
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.

Locations

Country	Name	City	State
Italy	AOU Careggi	Florence	Fi

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 rate	Oncologically negative resection rate	immediately after surgery
Secondary	(pCR);	Pathologic Complete Response rate	immediately after surgery
Secondary	(OS);	Overall Survival	through study completion, average of 36 months