Primary objective: to investigate the safety of RFA in non-metastasized, irresectable locally advanced pancreatic cancer.Secondary objectives: to determine VAS pain score, length of hospital stay, survival, progression free survival and CA19-9…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter of the phase II study is safety.
The safety will be specified as the percentage of patients with complications
directly related to RFA and 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, see table 3) [20]. The complications
directly related to RFA include pancreatitis, pancreatic fistula, perforation
of the duodenum and thermal damage of the porto-mesenterial vein. Moreover all
in-hospital complications or complications developed within 30 days after the
RFA procedure will be evaluated according to the Clavien-Dindo classification.
The study will have a follow-up period of 3 months.
Secondary outcome
Secondary outcome parameters of the study are: VAS pain score, length hospital
stay, survival, progression free survival and CA19-9 response.
Background summary
Pancreatic cancer is the most lethal abdominal malignancy and 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
non-metastasized irresectable locally advanced tumour and 40% with metastatic
disease. The median survival of patients with locally advanced pancreatic
cancer and metastatic disease is only 6 months. In patients with irresectable
locally advanced pancreatic cancer chemotherapy with Gemcitabine is considered
an accepted standard palliative treatment. However the survival benefit of
Gemcitabine is minimal. Therefore, there is an urgent need for new and more
effective therapies for patients with irresectable locally advanced disease.
Radiofrequency ablation (RFA) is a technique that has been demonstrated to be
effective in the treatment of several irresectable tumours. RFA produces local
tissue destruction through high frequency alternating current flowing from an
electrode implanted directly into the tumour. The ions in the tissue attempt to
follow the changing directions of the alternating current and cause frictional
heating. Heating to over 60°C is known to have damaging effects on cell
structure and physiology at many levels. A single RFA probe can be used as well
as a combination of 2 or 3 probes depending on the size of the tumour.
Promising results are reported in lung, bone, brain, kidney and prostate gland
tumours. The last ten years several studies of RFA of pancreatic cancer have
been performed as well. In several studies promising results of RFA of
irresectable locally advanced pancreatic cancer are reported, among others by
Girelli R. et al.
Study objective
Primary objective: to investigate the safety of RFA in non-metastasized,
irresectable locally advanced pancreatic cancer.
Secondary objectives: to determine VAS pain score, length of hospital stay,
survival, progression free survival and CA19-9 response.
Study design
The proposed study is a phase II non-randomized cohort study aimed at
collecting safety data in 17 patients. Continuous safety monitoring is used.
Intervention
The investigational treatment of this study is radiofrequency ablation.
Radiofrequency ablation of the pancreatic tumours will be produced through
application of high frequency alternating current flowing from a probe with an
electrode into the surrounding tissue. The ions in the tissue attempt to follow
the changing directions of the alternating current and cause frictional
heating. The tissue heats in the area that contacts the probe tip, and heat is
then transferred conductively to more distant tissue. This leads to denaturing
(coagulation) of the cellular proteins and subsequent necrosis of the affected
tissue volumes. The result is thermal injury of the cell structures and damage
of the cell physiology at many levels. The coagulated necrotic tissue is
recognized as such by the body and successively degraded by the body*s own
mechanisms. In this way, it is possible to completely destroy a tumour where
the indication is appropriate.
Study burden and risks
The prognosis of patients with irresectable locally advanced pancreatic cancer
is very poor. The median survival of these patients is only 6 months. The risk
of complications is 4-12% (see also E9). Considering the expected survival
benefit of RFA (more than 1 year reported in literature), we consider the
burden and risks of this treatment justified.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01628458 |
| CCMO | NL39333.041.11 |