Clinical trial NCT02709811: Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases
Official title: Safety and Feasibility of Electrochemotherapy in the Treatment of Unresectable Liver Metastases From Colorectal Adenocarninoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Colorectal Adenocarcinoma
Lead sponsor: IGEA
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Electrochemotherapy (ECT) is a non-thermal tumour ablation modality. It consists of the local potentiation, by means of local reversible electroporation of tumour tissues, of the antitumor activity of non-permeant or poorly permeant anticancer drugs already possessing intrinsic cytotoxicity. ECT has proved to be effective in the treatment of various cutaneous tumour nodules of any origin. Mostly ECT is offered to patients in case of multiple cutaneous metastases, when they cannot be excised, due to their number or localization. This study investigate the application of ECT in the treatment of liver metastases from colorectal adenocarcinoma, for which other thermal cytoreductive methods would be risky compared to the supposed expected clinical benefits.


Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 18 years of age
* Histological confirmed colorectal adenocarcinoma
* Histological or clinically confirmed metastatic colorectal adenocarcinoma lesions (liver lesions only are considered as metastatic disease) and not resecable.
* A single liver lesion may not exceed 3 cm
* Liver lesions must not have a depth greater than 2 cm from hepatic surface (Glisson Capsule) (measured clinically if possible otherwise on the basis of CT/ultrasound examination)
* A life expectancy of at least 6 months.
* Patients with a ECOG performance status \< 2
* Signed Informed Consent
* Patient must be mentally capable of understanding the information given.
* Patient must give informed consent.

Exclusion Criteria:

* Age less than 18 years.
* Patient pregnant or lactating (no contraceptive method is contraindicated, a pregnancy test will be administered to all women of childbearing age)
* Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies that preclude laparotomy
* Strumental analysis confirmed ascites.
* Impaired kidney function.
* Significant reduction in respiratory function.
* Allergic reaction to bleomycin.
* Coagulation disturbances
* Patients with exclusion criteria for diagnostic MRI 3Tesla (with pace-makers and all those metal devices that are not compatible with 3T).

Primary outcomes:
measure: Safety and feasibility evaluation of Electrochemotherapy treatment of liver metastasesSafety and feasibility evaluation of Electrochemotherapy treatment of liver metastases as meaured by unexpected intraoperative adverse events
timeFrame: 24 hours from Electrochemotherapy treatment
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months from Electrochemotherapy treatment
measure: Disease free survival
timeFrame: 6 months from Electrochemotherapy treatment
measure: Quality of Life (Karnofsky performance status)
timeFrame: 30 days and 6 months from ECT treatment
measure: Objective response evaluation of treated liver metastases following RECIST criteria
timeFrame: 30 days and 6 months from Electrochemotherapy treatment
measure: Toxicity of Electrochemotherapy treatment of liver metastases as meaured by unexpected postoperative complications related to treatment
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Pisa Medical School Hospital, Pisa, Italy
name: Franco Filipponi, MD
role: PRINCIPAL_INVESTIGATOR
References: