Document is current

Article History

Received: 4 December 2024

Accepted: 29 April 2025

First Online: 28 May 2025

Declarations

:

: The final protocol was approved by the Ethics Committee of the University of Zurich, Zurich, Switzerland (Zurich: 2024 − 00115). The X-SMILE study complies with the Helsinki Declaration in its recent German version, the principles of Good Clinical Practice (GCP) and the General Data Protection Regulation (GDPR) as well as the Federal Data Protection Act (FDPA). The trial will also be carried out in accordance with local legal and regulatory requirements. The ClinicalTrials.gov identifier is NCT06834152.

: Not applicable.

: Substantial changes to the project set-up, the protocol and relevant project documents will be submitted to the Ethics Committee for approval according to HRO Art. 18 before implementation.

: The sponsor had a role in the study design, but not in the collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The funder had no role in the study design, collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.

: Project data will be handled with uttermost discretion and is only accessible to authorized personnel who require the data to fulfil their duties within the scope of the research project. On the CRFs and other project specific documents, participants are only identified by a unique participant number. The project site personnel maintain a participant identification list, in which the participant identification numbers are linked to the full participant names and dates of birth. This list will be kept strictly confidential and must not leave the project site. After completion of the project, the participant identification list will be archived for 15 years. All clinical data entered into the database, including electronic case report forms (eCRFs), radiation treatment plans and imaging data, will only be transmitted in pseudonymized form.

: The insurance costs will be covered by the sponsor. Local insurance will be arranged in accordance with local regulations, where applicable. Policy Number: 14.970.888.

: Responsibility for the publication of the results lies with the project management. Until this time, all information on the research project must be treated confidentially. The final publication is planned for after the end of the project. All participating centers will be included in the publication, either as named authors or to the extent that the number of possible co-authors allows. Authors agree to make data and materials supporting the results or analyses presented in their paper available upon reasonable request.

: J.L. declares Speaker fee from Accuary and Traveling costs from Micropos Medical and from RaySearch Laboratories. The remaining authors declare no conflict of interest.