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RECRUITING
NCT05679427
NA

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Official title: A Randomised, Prospective, Monoinstitutional Study of Ablative Radiosurgery vs Stereotactic Radiotherapy in 5 Fractions, With Simultaneous Integrated Boost, for the Treatment of Bone Lesions in Oligometastatic Disease

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

307

Start Date

2022-11-07

Completion Date

2027-12-07

Last Updated

2025-06-11

Healthy Volunteers

No

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

Locations (1)

San Raffaele Scientific Institute

Milan, MI, Italy