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Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03187587
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Neoplasms Pancreatic Device: imILT Drug: Standard chemotherapy treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: imILT treatment
Immunostimulating Interstitial Laser Thermotherapy (imILT)
Device: 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.


Outcome Measures

Primary Outcome Measures :
  1. Treatment effect by radiology [ Time Frame: 12 months ]
    Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)


Secondary Outcome Measures :
  1. Safety assessed by the incidence the of adverse events [ Time Frame: 12 months ]
    Evaluation of adverse events and laboratory analyses.

  2. Usability (user evaluation of instrument) [ Time Frame: 12 months ]
    Analysis of instrument and user questionnaires relating to the ease of use.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Hemoglobin ≥9 g/dL
    2. Platelet count ≥75 x 109/L
    3. International normalized ratio (INR) ≤1.7
    4. WBC count ≥2 x 109/L
    5. Absolute neutrophil count (ANC) ≥1 x 109/L
    6. Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN)
    7. Serum chemistries sodium, potassium, and calcium within normal limits (WNL)
    8. 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187587


Contacts
Contact: Stefan Åström, PhD +46 (0)70 863 4909 stefan@astromresearch.com

Locations
Portugal
Portuguese Oncology Institute of Porto Recruiting
Porto, Portugal, 4200-072
Contact: Belarmino Goncalves, MD         
Sponsors and Collaborators
Clinical Laserthermia Systems AB
Investigators
Principal Investigator: Belarmino Goncalves, MD Portuguese Oncology Institute of Porto
More Information

Responsible Party: Clinical Laserthermia Systems AB
ClinicalTrials.gov Identifier: NCT03187587     History of Changes
Other Study ID Numbers: CTP-2015-006
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinical Laserthermia Systems AB:
Hyperthermia, Induced
Laser Coagulation
Laser Therapy