NCT03542214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

2.4 years

First QC Date

January 29, 2018

Last Update Submit

February 24, 2021

Conditions

Colorectal Cancer Stage IV

Outcome Measures

Primary Outcomes (1)

  • Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used)

    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.

    12 months

Secondary Outcomes (3)

  • Local response

    18 months

  • Systemic respons to calcium electroporation in colorectal cancer.

    12 months

  • Tumorregression

    12 months

Study Arms (1)

Calcium electroporation treatment

EXPERIMENTAL

Experimental treatment with calcium electroporation for inoperabel colorectal cancer

Combination Product: Calcium electroporation

Interventions

Calcium electroporationCOMBINATION_PRODUCT

Patients with inoperable colorectal cancer will be treated with calcium electroporation

Calcium electroporation treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Julie Gehl, DMSc

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

May 31, 2018

Study Start

April 24, 2018

Primary Completion

October 1, 2020

Study Completion

January 1, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

DK(1)