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

NCT07265661 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma of the Trunk and Extremities

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

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER

  • Italian Sarcoma Group

    lead NETWORK

Principal Investigators

  • Marco Baia, MD · Findazione IRCCS Istituto Nazionale Tumori Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2029-12-01
Completion
2035-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265661 on ClinicalTrials.gov