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Safety and Feasibility of imILT Locally Advanced Pancreatic Cancer (LAPC)

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. Read our disclaimer for details. Identifier: NCT02702986
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : November 22, 2019
Clinical Laserthermia Systems AB
Information provided by (Responsible Party):
Salvatore Paiella, MD, Universita di Verona

Brief Summary:
10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated as primary objective. Secondary objectives will be QoL after imILT, study of the immune reaction after imILT, oncological analysis of patients suffering from LAPC submitted to imILT.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: immunostimulating Interstitial Laser Thermotherapy Device: Laser Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunostimulating Interstitial Laser Thermotherapy in Patients With Locally Advanced Pancreatic Cancer: Results of a Prospective, Open, Non Comparative Study
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: imILT of pancreatic cancer
10 patients suffering from LAPC will be submitted to immunostimulating interstitial laser thermotherapy (imILT) in a single-arm setting
Procedure: immunostimulating Interstitial Laser Thermotherapy
Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.
Other Name: imILT

Device: Laser

Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. The immunostimulating effects of imILT [ Time Frame: Up to 24 months ]
    This will be determined by measuring plasma levels of various pro and anti-inflammatory cytokines and immune-related cells

  2. Quality of Life after the application of imILT on pancreatic cancer, using European Organisation for Research and Treatment of Cancer Quality of life Questionnaire C30 [ Time Frame: Up to 24 months ]
  3. Overall Survival [ Time Frame: Up to 24 months ]
  4. Progression free survival (PFS) [ Time Frame: Up to 24 months ]
  5. Disease specific survival (DSS) [ Time Frame: Up to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of stage III locally advanced pancreatic cancer
  • No further neoadjuvant treatments are doable
  • Eastern Cooperative Oncology Group performance status < 1

Exclusion Criteria:

  • No other concomitant oncological treatments (hormonal, immunotherapies, etc)
  • Suffering from other neoplasms
  • Suffering from HIV
  • Suffering from autoimmune diseases
  • Concomitant medication with steroids

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 identifier (NCT number): NCT02702986

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University of Verona Hospital
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Clinical Laserthermia Systems AB

Publications of Results:
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Responsible Party: Salvatore Paiella, MD, MD, Universita di Verona Identifier: NCT02702986    
Other Study ID Numbers: CTP-2015-001
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases