Status: in design
RESPECT
To guarantee independent and unbiased data collection and analysis requires the set-up of registries like RESPECT within independent scientific organisations such as CIRSE and Next Research.
While I am convinced of the performance of percutaneous ECT, RESPECT is important as it will embed the therapy in evidence-based knowledge, in the overall context of all other interventional oncology procedures.
Study summary
RESPECT is a European-wide, prospective, observational (non-interventional) study that gathers data on percutaneous electrochemotherapy (ECT) in patients with primary and secondary liver cancer. The registry observes the real-life use of the CLINIPORATOR® device in the context of the patients’ entire cancer treatment and collects extensive data regarding effectiveness, safety and toxicity, and treatment-related quality of life. The collection of real-life data is intended to form an large, multi-centric evidence-base of the therapies’ untilisation to treat primary and secondary liver cancer.
RESPECT spans the continent and aims to enrol up to 250 patients over an initial period of two years and a minimum follow-up of 24 months. The first patient is projected to be included in September 2022.
Endpoints
Primary objective
- To assess the effectiveness of percutaneous ECT performed with the CLINIPORATOR® device in controlling primary and secondary liver cancer.
Primary endpoint
- Effectiveness: local tumour control at 12 months on a per lesion basis measured according to mRECIST with CT or MRI imaging
Secondary endpoints
- Adverse events and toxicity (CTCAE 5.0)
- Overall survival
- Overall local disease-free survival
- Hepatic disease-free survival
- Quality of life (EORTC’s QLQ-C30)
- Pain
- Time to untreatable progression
- Systemic cancer therapy vacation
- Economic aspects
Steering Committee
| Name | Hospital |
|---|---|
| Attila Kovács (Co-Chairperson) | MediClin Robert Janker Klinik/DE |
| Philipp Wiggerman (Co-Chairperson) | Städtisches Klinikum Braunschweig gGmbH/DE |
| Dirk Arnold | Asklepios Tumorzentrum Hamburg/DE |
| Francois Cornelis | Memorial Sloan Kettering Cancer Center/US |
| Guiseppe Curigliano | Istituto Europeo di Oncologia/IT |
| Roberto Iezzi | Policlinico Universitario Agostino Gemelli/IT |
| Michael Moche | Helios Park-Klinikum Leipzig/DE |
| Franco Orsi | Istituto Europeo di Oncologia/IT |
| Tze Wah | Leeds Teaching Hospitals NHS Trust/UK |
Documents and links
- Project summary
- https://clinicaltrials.gov/ct2/show/NCT05267080