NCT01628458

Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Detailed description

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.

Conditions

• Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	radiofrequency ablation (RFA)	RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2012-06-26
• Last updated: 2015-02-02

Locations

1 site across 1 country: Netherlands