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Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer (RFA of LAPC)

This study is currently recruiting participants.
Verified September 2012 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
R. van Hillegersberg, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01628458
First received: June 20, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Locally Advanced Pancreatic Cancer
 Procedure: radiofrequency ablation (RFA)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study: Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Safety [ Time Frame: Within 30 days after the RFA procedure ] [ Designated as safety issue: Yes ]
    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:
  • survival [ Time Frame: 2 years after RFA procedure ] [ Designated as safety issue: No ]
  • VAS pain score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • length hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • progression free survival [ Time Frame: 2 years after RFA procedure ] [ Designated as safety issue: No ]
  • CA19-9 response [ Time Frame: 2 years after RFA procedure ] [ Designated as safety issue: No ]
  • Chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Type, frequency, dosage and duration of chemotherapy will be registered.


Estimated Enrollment: 17
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiofrequency ablation Procedure: radiofrequency ablation (RFA)
RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.
Other Name: CELON Power System, CE mark 0197

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628458

Contacts
Contact: Samira Fegrachi, MD, PhD fellow 0031-88-7556489 s.fegrachi@umcutrecht.nl
Contact: Richard van Hillegersberg, Professor 0031-88-7558074 r.vanhillegersberg@umcutrecht.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Principal Investigator: Quintus Molenaar, Surgeon            
Principal Investigator: Marc GH Besselink, Surgeon            
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Richard van Hillegersberg, Professor UMC Utrecht
  More Information

Publications:

Responsible Party: R. van Hillegersberg, Professor in surgery, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01628458     History of Changes
Other Study ID Numbers: 12-018
Study First Received: June 20, 2012
Last Updated: September 13, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Pancreatic cancer
locally advanced
irresectable
Radiofrequency
RFA

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013