Periodic Reporting for period 3 - STOPSTORM (A PROSPECTIVE EUROPEAN VALIDATION COHORT FOR STEREOTACTIC THERAPY OF RE-ENTRANT TACHYCARDIA)
Okres sprawozdawczy: 2024-05-01 do 2025-10-31
The STOPSTORM consortium consists of more than 30 clinical and research institutions and more than 20 External Registry Partners as well as an external advisory and ethics board, a patient advisory board and external observer groups, and investigates a promising new treatment for patients with refractory ventricular tachycardia (VT) which did not respond to conventional therapies like catheter ablation or anti-arrhythmic medication. This novel treatment uses a single, high-dose, non-invasive form of radiotherapy, which is well-known in cancer care as Stereotactic Body Radiotherapy (SBRT). For cardiac applications, this method is referred to as Stereotactic Arrhythmia Radioablation (STAR).
The STOPSTORM project is divided into nine work packages focused on establishing a comprehensive STAR treatment registry with associated quality assurance measures on target definition, data transport between cardiology and radiation oncology, contouring and treatment planning, treatment delivery and follow-up. To enable the broader application of STAR, more clinical and technical data is needed, especially since small initial studies have shown that treatment effects may not always be lasting. The goal of STOPSTORM is to achieve a Europe-wide standardization of STAR, which requires close collaboration between radiation oncologists, medical physicists, and cardiologists.
In the initial phase, the project focused on setting up the legal and logistical foundation for collecting STAR data across Europe. Initial findings revealed significant variation in STAR practices throughout Europe, which will serve as a baseline for the main goal: developing unified standards, guidelines, and workflows for STAR to support future standardization and harmonization of STAR across Europe. The first interim analysis of the STOPSTORM data showed promising results and already lead to several publications despite the delay and limited availability of the data at the beginning of the project.
The STOPSTORM project is divided into nine work packages focused on establishing a comprehensive STAR treatment registry with associated quality assurance measures on target definition, data transport between cardiology and radiation oncology, contouring and treatment planning, treatment delivery and follow-up. To enable the broader application of STAR, more clinical and technical data is needed, especially since small initial studies have shown that treatment effects may not always be lasting. The goal of STOPSTORM is to achieve a Europe-wide standardization of STAR, which requires close collaboration between radiation oncologists, medical physicists, and cardiologists.
In the initial phase, the project focused on setting up the legal and logistical foundation for collecting STAR data across Europe. Initial findings revealed significant variation in STAR practices throughout Europe, which will serve as a baseline for the main goal: developing unified standards, guidelines, and workflows for STAR to support future standardization and harmonization of STAR across Europe. The first interim analysis of the STOPSTORM data showed promising results and already lead to several publications despite the delay and limited availability of the data at the beginning of the project.
A new treatment approach for difficult-to-treat heart rhythm problems, specifically for patients with Ventricular Tachycardia (VT) that hasn’t responded to other treatments, is being tested. Known as STereotactic Arrhythmia Radioablation (STAR), this treatment adapts a method from cancer therapy to target heart tissue non-invasively. To expand this promising treatment, more clinical and technical data is needed from a larger number of patients.
In the initial phase of the STOPSTORM project, the consortium of over 30 centers was formed, and the groundwork was laid for data collection. This included aligning legal and logistical requirements across countries, establishing the STAR registry infrastructure, and designing initial clinical trials. Early studies and surveys revealed significant differences in STAR practices across sites, setting a baseline for future standardization efforts.
In the second phase, prospective clinical trials for STAR began in each participating country, and data entry into the registry started. The first guidelines on STAR were developed and shared through conferences and publications. Additionally, a patient advisory board was established to guide patient-centered resources, and more European centers joined as external partners to increase patient recruitment. This phase concluded with a seamless transition of the project’s coordinating center, maintaining steady progress despite minor delays.
In the third period we caught up with most delays after the completion of the transition of the coordinating centre and the on-boarding of all new External Registry Partner to register STAR patients into the STOPSTORM database. The data collection of the observation cohort (patient treated before the start of the STOPSTORM consortium) has been concluded and data can be analysed soon. The data collection of the harmonized cohort (patient treated after the start of the STOPSTORM consortium) is ongoing in almost 40 centres and overall, more than 300 patients have already been registered in the STOPSTORM database at the end of the third period (recruitment goal reached). Additionally, numerous additional project analyses are in preparation adding to the already well-published project with over 15 direct STOPSTORM and over 60 STAR related manuscripts from the many consortium centres. Furthermore, the consortium generated comprehensive high quality benchmark documents for radiotherapy (auto)-contouring and treatment planning studies and for invasive and non-invasive electro-anatomical mapping as well as standardized workflows for accurate target delineation and transfer to radiotherapy planning systems, and a clinical consensus statement by the European Heart Rhythm Society (EHRA) providing practical advice for the implementation of STAR. A clinical consensus statement by the European Society for Radiation Oncology (ESTRO) is additionally in preparation. Finally, the planned interim analysis highlighted that STAR reduces the number of VT episodes as well as the VT burden. It was also shown that many adverse events were unlikely to be STAR-related. Lastly, motion and its dosimetric effect have similar magnitudes between treatment setups and were found to be patient-specific. These and other results from ethical research and from meta-analyses were disseminated largely and discussed with the several boards of the consortium (e.g. patient advisory board, external advisory board, and external observer groups).
In the initial phase of the STOPSTORM project, the consortium of over 30 centers was formed, and the groundwork was laid for data collection. This included aligning legal and logistical requirements across countries, establishing the STAR registry infrastructure, and designing initial clinical trials. Early studies and surveys revealed significant differences in STAR practices across sites, setting a baseline for future standardization efforts.
In the second phase, prospective clinical trials for STAR began in each participating country, and data entry into the registry started. The first guidelines on STAR were developed and shared through conferences and publications. Additionally, a patient advisory board was established to guide patient-centered resources, and more European centers joined as external partners to increase patient recruitment. This phase concluded with a seamless transition of the project’s coordinating center, maintaining steady progress despite minor delays.
In the third period we caught up with most delays after the completion of the transition of the coordinating centre and the on-boarding of all new External Registry Partner to register STAR patients into the STOPSTORM database. The data collection of the observation cohort (patient treated before the start of the STOPSTORM consortium) has been concluded and data can be analysed soon. The data collection of the harmonized cohort (patient treated after the start of the STOPSTORM consortium) is ongoing in almost 40 centres and overall, more than 300 patients have already been registered in the STOPSTORM database at the end of the third period (recruitment goal reached). Additionally, numerous additional project analyses are in preparation adding to the already well-published project with over 15 direct STOPSTORM and over 60 STAR related manuscripts from the many consortium centres. Furthermore, the consortium generated comprehensive high quality benchmark documents for radiotherapy (auto)-contouring and treatment planning studies and for invasive and non-invasive electro-anatomical mapping as well as standardized workflows for accurate target delineation and transfer to radiotherapy planning systems, and a clinical consensus statement by the European Heart Rhythm Society (EHRA) providing practical advice for the implementation of STAR. A clinical consensus statement by the European Society for Radiation Oncology (ESTRO) is additionally in preparation. Finally, the planned interim analysis highlighted that STAR reduces the number of VT episodes as well as the VT burden. It was also shown that many adverse events were unlikely to be STAR-related. Lastly, motion and its dosimetric effect have similar magnitudes between treatment setups and were found to be patient-specific. These and other results from ethical research and from meta-analyses were disseminated largely and discussed with the several boards of the consortium (e.g. patient advisory board, external advisory board, and external observer groups).
The project builds on a close collaboration between radiation oncologists and electrophysiologists: medical specialists that normally do not have close encounters due to non-overlapping patient populations. Raising the collaboration to a European level sparked a great enthusiasm in the collaborators, intensifying local, national and international progress in the field. As side effect from the project, electrophysiologists started to exchange knowledge on the standard procedures, increasing effectivity in some cases. Radiation oncologists saw the same positive effects from collaboration and bench marking of their departments. At the end of the project, electrophysiology and radiotherapy will have become better as parts, but also as collaborative treatments.
On education, multiple national symposia on STAR were organized in the STOPSTORM member states as well as several satellite symposiums were held together with experts from the USA and other countries prior to large congresses (SNOSTORM Meetings). The scientific community acknowledges the increased use of STAR and its good clinical outcome with several invited talks at major EU society conferences (and abroad) as well as with guidelines and consensus statements. Continued education on STAR within and outside the STOPSTORM consortium is supplemented by STAR program start-up support, training centres, the Journal Club, and several webinars in the third period of the project.
On education, multiple national symposia on STAR were organized in the STOPSTORM member states as well as several satellite symposiums were held together with experts from the USA and other countries prior to large congresses (SNOSTORM Meetings). The scientific community acknowledges the increased use of STAR and its good clinical outcome with several invited talks at major EU society conferences (and abroad) as well as with guidelines and consensus statements. Continued education on STAR within and outside the STOPSTORM consortium is supplemented by STAR program start-up support, training centres, the Journal Club, and several webinars in the third period of the project.