NCT07265661

Surgical Timing After Preoperative Hypofractionated Radiotherapy for Localized Extremity and Trunk Soft Tissue Sarcoma

Surgical Timing After Preoperative Hypofractionated Radiotherapy for Patients With Primary Localized Soft Tissue Sarcoma of the Extremity and Trunk: a Randomized Phase 2 Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, national, multicentric, prospective, randomized (1:1) non-inferiority trial with two parallel groups, incorporating a concurrent observational cohort of eligible non-randomized patients, designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk.

Detailed description

This study is designed to address critical knowledge gaps by prospectively evaluating the safety, efficacy, and feasibility of preoperative ultra-hypofractionated radiotherapy (HFRT) in patients with soft tissue sarcomas (STS) of the extremities and trunk. Eligible patients will be randomized to receive an ultra-hypofractionated RT regimen consisting of 30 Gy delivered in 5 fractions of 6 Gy, followed by surgical resection at one of two predefined intervals: either 1-2 weeks or 4-6 weeks after completion of radiotherapy. In parallel, a non-randomized observational cohort will be recorded, consisting of patients treated according to current standard practice - surgery alone or surgery preceded by nonventional RT (50 Gy in 25 fractions) - to provide a contemporaneous benchmark for comparison. The aim of this study is to gather high-quality clinical evidence on the impact of ultra-hypofractionated RT on oncologic outcomes, treatment-related toxicity, perioperative morbidity, and patient-reported quality of life. Evaluation of logistical and economic implications of treatment de-escalation, such as healthcare resource utilization and treatment burden are also an important point to be addressed. By systematically assessing these endpoints, this study aims to inform future clinical guidelines and support the potential integration of ultra-hypofractionated RT into routine clinical practice for selected patients with localized STS.

Conditions

• Soft Tissue Sarcoma of the Trunk and Extremities

Interventions

Type	Name	Description
PROCEDURE	hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment	hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 1-2 weeks after treatment
PROCEDURE	hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment	hypofractionated radiotherapy (30Gy/5 fractions) and surgical resection at 4-6 weeks after treatment

Timeline

• Start date: 2026-01-30
• Primary completion: 2029-12-01
• Completion: 2035-12-01
• First posted: 2025-12-05
• Last updated: 2026-01-06