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NOT YET RECRUITING
NCT07265661
NA

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

Sponsor: Italian Sarcoma Group

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2026-01-30

Completion Date

2035-12-01

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

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