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Article History

Received: 11 August 2024

Accepted: 8 November 2024

First Online: 18 December 2024

Declarations

:

: The final protocol received approval from the ethics committee of Fondazione Policlinico Universitario “A. Gemelli”, IRCCS of Rome, Italy (ethics committee identifier code 5579). Any modification to the protocol that could impact the study execution, potential patient benefit, or safety, such as changes in study objectives, study design, patient population, sample size, study procedures, or significant administrative aspects, will require a formal protocol amendment. This amendment must be endorsed by the Ethics Committee. Patient recruitment will extend to the other affiliated Italian hospitals (“SS Annunziata” Hospital, “G. d’Annunzio” University, Chieti; Responsible Research Hospital, Campobasso; Azienda Ospedaliera Universitaria delle Marche, Ancona; CNAO, National Center of Oncological Hadrontherapy, Pavia; IEO European Institute of Oncology, IRCCS, Milan) and any centres that would like to participate, after approval of the protocol by their respective ethics committees. This study adheres to the latest version of the Declaration of Helsinki and complies with Italian laws and regulations. The protocol has been written according to the principles of good clinical practice (GCP). Patients are provided with comprehensive information about the rationale for the treatment, the potential benefits and the possible side effects before they voluntarily sign the informed consent form. No interventions are performed until the informed consent form has been duly signed.

: Not applicable.

: All authors declare that they have no competing interests<b>.</b>