Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma

Conditions
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Neoplasms Pancreatic

Intervention / Treatment
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* Device: imILT
* Drug: Standard chemotherapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage II-III) or of stage IV disease with hepatic metastasis (staging according to UICC 2009) Locally advanced disease shall have a lesion diameter less than 4cm If stage IV disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter The patient is a candidate for standard chemotherapy (as described at point 5.1) Age between 18 and 80 years, males and females Anticipated compliance with treatment and follow-up Have given informed verbal and written consent to participation in the trial Have stable and adequate haematologic, renal and hepatic functions: Hemoglobin ≥9 g/dL Platelet count ≥75 x 109/L International normalized ratio (INR) ≤1.7 WBC count ≥2 x 109/L Absolute neutrophil count (ANC) ≥1 x 109/L Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN) Serum chemistries sodium, potassium, and calcium within normal limits (WNL) Serum creatinine <2.0 mg/dL or creatinine clearance >60 mL/min according to Cockroft-Gault formula At least a part of the tumour can be treated with imILT without damage to adjacentvital structures Have an ECOG performance status <2 (Karnofsky> 60%) Exclusion Criteria: HIV 1 or 2 positive Active autoimmune disease which is judged to reduce an anti-tumour immune response Pregnancy or breast feeding Have known bleeding disorder that cannot be managed accordingly with the protocol rules, such severe acute or chronic liver failure, other genetic blood diseases not properly managed prior to treatment or other any disease treated with anticoagulant or anti-platelet medication that cannot be interrupted prior to treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imILT treatment<br>Immunostimulating Interstitial Laser Thermotherapy (imILT) | Device: imILT<br>* The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.<br>* Other names: TRANBERG Thermal Therapy System;|
| Active Comparator: Standard chemotherapy treatment<br>This study arm recieves chemotherapy treatment as standard care at the clinical study site. | Drug: Standard chemotherapy treatment<br>* The standard chemotherapy treamtment arm recieves only chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effect by radiology | Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by the incidence the of adverse events | Evaluation of adverse events and laboratory analyses. | 12 months | 
| Usability (user evaluation of instrument) | Analysis of instrument and user questionnaires relating to the ease of use. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperthermia, Induced, Laser Coagulation, Laser Therapy