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Calcium Electroporation for Early Colorectal 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: NCT03694080
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
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Brief Summary:
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Combination Product: Calcium electroporation Phase 1

Detailed Description:

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer.

In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment.

Patients will be followed for one month after the elective surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcium Electroporation for Early Colorectal Cancer
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : September 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Calcium Electroporation treatment
Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.
 Combination Product: Calcium electroporation
Patients with potentially curable colorectal rectal cancer will be treated preoperatively


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 42 days ]
    Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used


Secondary Outcome Measures :
  1. Histopathological characterization of the tumor [ Time Frame: 14 days ]
    ypTNM staging and tumor regression grade according to current standards

  2. Immunologic infiltration of the tumor tissue after calcium electroporation [ Time Frame: 14 days ]
    Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.

  3. Immunoscore classification [ Time Frame: 14 days ]
    Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.

  4. Systemic immune response according to cytokine analysis [ Time Frame: 42 days ]
    Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed

  5. Systemic immune response according to flow cytometri [ Time Frame: 42 days ]
    Blood samples will be collected prior to calcium electroporation and again at follow-up. Flow cytometri will be performed to evaluate immunological changes to the treatment.

  6. Metastatic ability after potentially curable surgery [ Time Frame: 42 days ]
    Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.

  7. Cell proliferation as a marker for metastatic ability [ Time Frame: 42 days ]
    Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability


Eligibility Criteria
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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:

  • • Patients must be mentally capable of understanding the information given.

    • Patients must give written informed consent.
    • Histologically verified adenocarcinoma of the rectum or sigmoid colon.
    • Tumor described as passable at index endoscopy.
    • Men or women aged at least 18 years.
    • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
    • ASA class I-II (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

  • • Uncorrectable coagulation disorder.

    • Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
    • Patients with ICD or pacemaker units.
    • Ongoing immunosuppressive treatment.
    • Patients with concomitant use of phenytoin.
    • Concurrent treatment with an investigational medicinal product.
    • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
    • Advanced tumor stages, clinical UICC stage IV.
    • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
    • Acute surgical resection.
    • Pregnancy
Contacts and Locations
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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): NCT03694080


Contacts
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Contact: Malene Broholm Andersen, MD +45 41272742 malea@regionsjaelland.dk
Contact: Ismail Gögenur, DMSc igo@regionsjaelland.dk

Locations
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Denmark
Department of Surgery, Zealand University Hospital Recruiting
Køge, Denmark, 4600
Contact: Malene Broholm, MD    +45 41272742    malea@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Ismail Gögenur, DMSc Zealand University Hospital
More Information
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03694080    
Other Study ID Numbers: REG-188-2017
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs