Innovative surgery as the cornerstone of affordable multi-modal therapeutic interventions benefitting cancer patients with locally advanced or metastatic disease

Cancer surgery[[A non-exhaustive list of types of surgeries: open surgery, minimally-invasive surgery using laparoscopy or endoscopy, robotic surgery, laser surgery, cryosurgery, radiosurgery (such as ‘gammaknife’, cyberknife, radiofrequency and microwave ablation). ]] represents the main first line treatment for solid tumours. While cancer patients with locally advanced or metastatic disease across Europe are often excluded from clinical studies, they would benefit from access to tailored, affordable, innovative, surgery-centred interventions, which are adapted to an increasingly precision oncology healthcare landscape.

Proposals should address all of the following:

• Validate innovative surgery-centred, multi-modal treatment interventions to treat cancer patients with locally advanced or metastatic disease. When appropriate, investigators should consider minimally-invasive surgical treatment interventions combined with either relevant medical devices or other multimodal treatment interventions[[A non-exhaustive list of other treatment interventions to combine with innovative surgery may include: intra-operative radiotherapy, chemotherapy, electro-chemotherapy, photodynamic therapy, radiotherapy, targeted therapy, immunotherapy, hyperthermia or thermal ablation, transplantation or any other combination]];
• The chosen surgery-centred intervention(s) should be validated through academic investigator-initiated clinical trials. Translational research is limited to supporting the conduct and analyses of the proposed clinical trial(s);
• The chosen surgery-centred treatment intervention(s) should be adapted to the needs of the target population and the specificities of healthcare provision at local, regional, or national level, duly reflecting the (cultural) diversity and available resources across Member States and Associated Countries. Data should be disaggregated by sex, gender, age and other relevant variables, such as by measures of socio-economic status or ethnicity;
• The primary and secondary endpoints of the clinical trial(s) should support overall survival, patient-reported outcomes and quality of life issues. Such endpoints should be defined together with patients and their caregivers through research that stimulates social innovation and supports end-user engagement using participative research models;
• Affordability of the chosen surgery-centred treatment intervention(s) should be demonstrated via a cost-effectiveness analysis.
• Include an appropriate mix of stakeholders from various disciplines and sectors, such as physicians, academia, patients and their caregivers, patient representatives, SMEs, insurance companies, engineers, physicists, charities, foundations, research and innovation organisations, civil society, regional as well as national health authorities;
• All datasets produced should be described with metadata records in the EU dataset catalogue of the European Health Data Space while all tools and models should take advantage of current European research infrastructures, should follow the principles of open science and be made available through the future UNCAN.eu platform[[https://healthdcat-ap.github.io/]].

This topic requires the effective contribution of Social Sciences and Humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise in the successful proposal, to produce meaningful and significant effects enhancing the societal impact of the related research activities.

The successful proposals are expected to build on resources made available by the Knowledge Centre on Cancer (KCC)[[Hosted by the European Commission's Joint Research Centre (JRC). Especially through the ’European Guidelines and Quality Assurance Schemes for Breast, Colorectal and Cervical Cancer Screening and Diagnosis‘, and the ’European Cancer Information System (ECIS)’ and the ’European Cancer Inequalities Registry (ECIR), see https://knowledge4policy.ec.europa.eu/cancer_en ]] to foster EU alignment and coordination.

The Commission will facilitate coordination. Therefore, successful proposals will be asked to join the 'Diagnosis and Treatment' cluster for the Cancer Mission[[In order to address the objectives of the Cancer Mission, participants will collaborate in project clusters to leverage EU-funding, increase networking across sectors and disciplines, and establish a portfolio of Cancer Mission R&I and policy actions. ]] and should include a budget for networking, attendance at meetings, and joint activities[[Examples of those activities are research or research capacity, organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. Proposals are not required to include details of these activities, as they will be defined during the grant agreement preparation and during the life of the project. ]].

Applicants should provide details of the clinical studies in the dedicated annex using the template provided in the submission system.