Clinical trial NCT01628458: Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Official title: Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Keywords: Pancreatic cancer
locally advanced
irresectable
Radiofrequency
RFA
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: Within 30 days after the RFA procedure
Secondary outcomes:
measure: survival
timeFrame: 2 years after RFA procedure
measure: VAS pain score
timeFrame: 3 months
measure: length hospital stay
timeFrame: 3 months
measure: progression free survival
timeFrame: 2 years after RFA procedure
measure: CA19-9 response
timeFrame: 2 years after RFA procedure
measure: Chemotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Richard van Hillegersberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cantore M, Girelli R, Mambrini A, Frigerio I, Boz G, Salvia R, Giardino A, Orlandi M, Auriemma A, Bassi C. Combined modality treatment for patients with locally advanced pancreatic adenocarcinoma. Br J Surg. 2012 Aug;99(8):1083-8. doi: 10.1002/bjs.8789. Epub 2012 May 30.
citation: Girelli R, Frigerio I, Salvia R, Barbi E, Tinazzi Martini P, Bassi C. Feasibility and safety of radiofrequency ablation for locally advanced pancreatic cancer. Br J Surg. 2010 Feb;97(2):220-5. doi: 10.1002/bjs.6800.