Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Sponsor

Azienda Ospedaliero-Universitaria Careggi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05761054

Collaborator

(none)

Enrollment

Location

Arm

59.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Radiation: RT	N/A

Detailed Description

/ 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Actual Study Start Date :

Jul 19, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	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.

Arm

Intervention/Treatment

Experimental: A

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.

Outcome Measures

Primary Outcome Measures

R0 rate [immediately after surgery]
Oncologically negative resection rate

Secondary Outcome Measures

(pCR); [immediately after surgery]
Pathologic Complete Response rate
(OS); [through study completion, average of 36 months]
Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Careggi	Florence	Fi	Italy	50134

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Careggi

Investigators

Principal Investigator: lorenzo livi, Dr, AOU Careggi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lorenzo Livi, Professor, Azienda Ospedaliero-Universitaria Careggi

ClinicalTrials.gov Identifier:

NCT05761054

Other Study ID Numbers:

SPRINT

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Lorenzo Livi, Professor, Azienda Ospedaliero-Universitaria Careggi

soft tissue sarcoma (STS)

Intensity Modulated Radiotherapy (IMRT)

boost

radiotherapy

locally advanced soft tissue sarcoma

Additional relevant MeSH terms:

Sarcoma

Study Results

No Results Posted as of Mar 9, 2023