Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Phase 2

Completed

• Conditions: Locally Advanced Pancreatic Cancer
• Interventions: Procedure: radiofrequency ablation (RFA)

• Registration Number: NCT01628458
• Lead Sponsor: UMC Utrecht

Brief 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.

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-26
• Study Start: 2012-09
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
2. Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
3. Fully informed written consent given

Exclusion Criteria

1. Patients younger than 18 years
2. Pregnancy
3. Patients with distant metastases
4. Portal vein thrombosis seen on CT preoperatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiofrequency ablation	radiofrequency ablation (RFA)	-

Primary Outcome Measures

Name	Time	Method
Safety	Within 30 days after the RFA procedure	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.

Secondary Outcome Measures

Name	Time	Method
Chemotherapy	2 years	Type, frequency, dosage and duration of chemotherapy will be registered.
length hospital stay	3 months
progression free survival	2 years after RFA procedure
survival	2 years after RFA procedure
CA19-9 response	2 years after RFA procedure
VAS pain score	3 months

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands