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Trial record 4 of 9 for:    calcium electroporation
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Calcium Electroporation for the Treatment of 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: NCT03542214
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE May 31, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)		 Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used) [ Time Frame: 12 months ]
Safety will be assessed through registration of adverse events related to the treatment. Furthermore, CT scans and follow-up endoscopies are performed as a safety marker to exclude any perforations, bleeding or infections. CTCAE v4 will be used.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • Local response [ Time Frame: 18 months ]
    Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)
  • Systemic respons to calcium electroporation in colorectal cancer. [ Time Frame: 12 months ]
    Blood samples will be collected. Multiplex cytokine analyses and transcriptional analyses will be performed. Furthermore cell adhesion assay will be performed. Additionally circulating tumor DNA will be measured as a marker for the tumor burden
  • Tumorregression [ Time Frame: 12 months ]
    CT/MR scans are performed and analyzed according to RECIST-criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcium Electroporation for the Treatment of Colorectal Cancer
Official Title  ICMJE Calcium Electroporation for the Treatment of Colorectal Cancer
Brief Summary In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.
Detailed Description

A total of 6 evaluable patients with inoperable colorectal cancer are expected to be included in the study and the time for inclusion of patients is estimated to be 1-2 years. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.

All patients will be treated once, but in case of residual tumor tissue at follow-up, and if the investigator considers it safe, they will be offered re-treatment. A maximum of 3 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 12 months, starting from first treatment day.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Colorectal Cancer Stage IV
Intervention  ICMJE Combination Product: Calcium electroporation
Patients with inoperable colorectal cancer will be treated with calcium electroporation
Study Arms  ICMJE Experimental: Calcium electroporation treatment
Experimental treatment with calcium electroporation for inoperabel colorectal cancer
Intervention: Combination Product: Calcium electroporation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2018)		 6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically verified colorectal tumor
  • Conferred by multidisciplinary team (radiologists, surgeons and oncologists) discussing options possible for the patient, resulting in agreement that an endoscopic treatment with calcium electroporation should be offered to the patient.
  • Treatment free interval of minimum 2 weeks.
  • Thrombocytes ≥ 50 billions/l, INR >1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K.
  • Performance status ECOG/WHO ≤2
  • Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.)
  • Trial subject ≥ 18 years.
  • Trial subject must be able to understand the participants' information.
  • Signed informed consent. The patients are considered participants in the study after signing of the informed consent.

Exclusion criteria:

  • Coagulative disturbance that cannot be corrected
  • Pregnancy or lactation (Pregnancy is ruled out in fertile women by an HCG test in a blood sample)
  • Concurrent participation in other clinical trials that involve experimental drugs or participation in a clinical trial involving experimental drugs within 4 weeks prior to administration of the drug in this study.
  • Treatment with bevacizumab within the last 4 weeks.
  • Heavily inflamed colorectal mucus membrane with bleeding or ulcerations.
  • Implanted colon stent
  • Other clinical disease or previous treatments that make the investigator deem the patient unfit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Malene Broholm Andersen, MD +45 41272742 malea@regionsjaelland.dk
Contact: Julie Gehl, DMSc kgeh@regionsjaelland.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03542214
Other Study ID Numbers  ICMJE HGH-2017-026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zealand University Hospital
Study Sponsor  ICMJE Zealand University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Gehl, DMSc Zealand University Hospital
PRS Account Zealand University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP