Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma|
- Treatment effect by radiology [ Time Frame: 12 months ]Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
- Safety assessed by the incidence the of adverse events [ Time Frame: 12 months ]Evaluation of adverse events and laboratory analyses.
- Usability (user evaluation of instrument) [ Time Frame: 12 months ]Analysis of instrument and user questionnaires relating to the ease of use.
|Actual Study Start Date:||May 17, 2017|
|Estimated Study Completion Date:||April 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: imILT treatment
Immunostimulating Interstitial Laser Thermotherapy (imILT)
The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.
Active Comparator: Standard chemotherapy treatment
This study arm recieves chemotherapy treatment as standard care at the clinical study site.
Drug: Standard chemotherapy treatment
The standard chemotherapy treamtment arm recieves only chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03187587
|Contact: Stefan Åström, PhD||+46 (0)70 863 firstname.lastname@example.org|
|Portuguese Oncology Institute of Porto||Recruiting|
|Porto, Portugal, 4200-072|
|Contact: Belarmino Goncalves, MD|
|Principal Investigator:||Belarmino Goncalves, MD||Portuguese Oncology Institute of Porto|