Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer related death in the Western world.
At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an
irresectable locally advanced tumour (without metastases) and 40% with metastatic disease.
The median survival of patients with irresectable locally advanced pancreatic cancer is only
6 months. Currently, there is no effective treatment for these patients. Therefore, there is
an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been
demonstrated to be effective in the treatment of several irresectable tumours. RFA produces
local tumour destruction through high frequency alternating current flowing from an
electrode implanted directly into the tumour and causing frictional heating. The purpose of
this study is to determine the safety of RFA-pancreas in patients with non-metastasized,
irresectable, locally advanced pancreatic cancer.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The safety will be specified as the percentage of patients with complications directly related to RFA and the routinely performed double-bypass procedure, requiring re-intervention (i.e. endoscopy, radiology, or surgery). This is also known as a complication of grade III or higher in the Clavien-Dindo classification (internationally accepted classification for surgical complications). Moreover all in-hospital complications or complications developed within 30 days after the RFA procedure will be evaluated according to the Clavien-Dindo classification.
Within 30 days after the RFA procedure
Richard van Hillegersberg, Professor
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)