Clinical trial NCT03542214: Calcium Electroporation for the Treatment of Colorectal Cancer
Official title: Calcium Electroporation for the Treatment of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer Stage IV
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used)
timeFrame: 12 months
Secondary outcomes:
measure: Local response
timeFrame: 18 months
measure: Systemic respons to calcium electroporation in colorectal cancer.
timeFrame: 12 months
measure: Tumorregression
timeFrame: 12 months
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Julie Gehl, DMSc
role: PRINCIPAL_INVESTIGATOR
References: