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Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)

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: NCT04093141
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital

Brief Summary:

This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC).

The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.


Condition or disease Intervention/treatment Phase
Unresectable Pancreatic Cancer Procedure: IRE Not Applicable

Detailed Description:

Patients with unresectable LAPC can be included in the study. Prior to inclusion, initial treatment with chemotherapy with or without radiation therapy (RT) is administered to all patients accord to the referring institutions protocol. Some patients will have undergone an attempted resection prior to inclusion. It is expected, that a substantial number of patients are participants in the LAPC-03 protocol (FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with LAPC).

After completion of initial therapy, potential study participants are restaged with a PET-CT scan and serum tumor markers. Patients found on restaging to be free of metastatic disease and without significant primary tumor progression will be candidates for IRE therapy. IRE therapy will be administered not earlier than 2 weeks after completion of initial therapy.

IRE will be done under general anesthesia as an in-patient procedure. Patients will attend study specific visits with PET-CT scan 3, 6, 9, 12, 18 and 24 months post-IRE. Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 15, 18, 21 and 24 months. During this we will monitor pain, quality of life, global functioning and nutritional status.

In patients who, at any time during the study, are assessed as candidates for resection, a more detailed re-evaluation of resectability is performed according to local preferences (e.g. EUS and/or LAP/LUS and/or CT and/or MR).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients in the study will be compared to data from clinical registry.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Procedure: IRE
in situ irreversible electroporation
Other Name: irreversible electroporation




Primary Outcome Measures :
  1. 2-year survival proportion from 1) diagnosis and 2) IRE [ Time Frame: 2 years after the last patient is enrolled ]

Secondary Outcome Measures :
  1. Median overall survival from 1) diagnosis and 2) IRE [ Time Frame: 2 years after the last patient is enrolled ]
  2. Progression free survival after IRE [ Time Frame: 2 years after the last patient is enrolled ]
  3. Median time to local progression after IRE [ Time Frame: 2 years after the last patient is enrolled ]
  4. Median time to dissemination after IRE [ Time Frame: 2 years after the last patient is enrolled ]
  5. 90-day complication rate and severity (Clavien-Dindo) [ Time Frame: 90 days after the last patient is enrolled ]
  6. Resection rate [ Time Frame: 2 years after the last patient is enrolled ]
  7. Quality of life (EORTC QLQ C-30) [ Time Frame: Every 3 months for 2 years after the intervention ]
    Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial we be calculated seperately.

  8. Perioperative pain perception (VAS) [ Time Frame: Every week for 1 month after the intervention ]
    Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).

  9. Long term pain perception (m-BPI-SF) [ Time Frame: Every 3 months for 2 years after the intervention ]
    Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).

  10. ECOG performance status [ Time Frame: Every 3 months for 2 years after the intervention ]
    Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" perfomance status scale (range 0 - 5, low score is better)

  11. Nutritional status assessment (PG-SGA-SF) [ Time Frame: Every 3 months for 2 years after the intervention ]
    Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37,low score is better).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytologically proven adenocarcinoma/carcinoma of the pancreas.
  • Largest tumor diameter ≤4 cm in any plane.
  • >18 years of age.
  • Prior treatment with neoadjuvant chemotherapy for at least 2 months
  • Tumor must be deemed as unresectable at the national pancreatic multidisciplinary team conference after neoadjuvant treatment.
  • Non-progressive disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECiST 1.1) after neoadjuvant treatment.
  • Patients must be able to give informed consent.

Exclusion Criteria:

  • Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound).
  • ASA score >3
  • ECOG performance status >2
  • Pregnancy.
  • Atrial fibrillation.
  • Implanted electronic device e.g. cardiac pacemakers or other electrostimulators.
  • Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE).
  • Signs of severe disease of the bone marrow, kidney or liver during time of treatment. Treatment may be postponed if the disease state is reversible.
  • Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
  • Patient is referred from hospital outside of Denmark

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): NCT04093141


Contacts
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Contact: Rasmus Virenfeldt Flak, MD +4597661181 rasmus.virenfeldt@rn.dk
Contact: Mogens Tornby Stender, Consultant surgeon, PhD +4597661761 mogens.stender@rn.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Rasmus Virenfeldt Flak, MD    +4597661181    rasmus.virenfeldt@rn.dk   
Contact: Mogens Tornby Stender, Consultant Surgeon, PhD    +4597661761    mogens.stender@rn.dk   
Sponsors and Collaborators
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Investigators
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Principal Investigator: Ole Thorlacius-Ussing, Professor, DMSc Department of gastrointestinal surgery, Aalborg University Hospital

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Responsible Party: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Professor of surgery, Consultant surgeon, DMSc, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04093141    
Other Study ID Numbers: N-20190013
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital:
locally advances pancreatic cancer
irreversible electroporation
nanoknife
phase II
efficacy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases