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Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions

NCT05679427 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2025-06-11

No results posted yet for this study

Summary

This is a randomised prospective monoinstitutional study comparing radiosurgery at a total dose up to 24 Gy to five fraction stereotactic radiotherapy with simultaneous integrated boost (SIB) up to 50 Gy for the treatment of bone metastases in oligometastatic cancer treated with radical intent. At the end of the first 12 months from the start of the study an interim analysis will be performed taking into account all major endpoints for an initial evaluation of the study , with only an observational purpose, without subsequent protocol changes.

Conditions

  • Oligometastatic Disease

Interventions

RADIATION

radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively

Two protocols of stereotactic ablative radiotherapy, in one vs five fractions ( the later with SIB) are compared

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Nadia G Di Muzio, Prof · IRCCS San Raffaele, Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2025-11-07
Completion
2027-12-07

Countries

  • Italy

Study Locations

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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 NCT05679427 on ClinicalTrials.gov