Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method performed pecutaneously in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety of the method. This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic cancer will be treated in this trial, ten recieving imILT treatment and ten recieving standard chemotherapy. The study is estimated to be carried out during a time period of 21 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.
The standard chemotherapy treamtment arm recieves only chemotherapy.
Portuguese Oncology Institute of Porto
Porto, Portugal
Treatment effect by radiology
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
Time frame: 12 months
Safety assessed by the incidence the of adverse events
Evaluation of adverse events and laboratory analyses.
Time frame: 12 months
Usability (user evaluation of instrument)
Analysis of instrument and user questionnaires relating to the ease of use.
Time frame: 12 months
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