Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases

NCT ID: NCT02709811

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-01-31

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.

Conditions

Colorectal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

electrochemotherapy

Group Type: EXPERIMENTAL

Electrochemotherapy

Intervention Type: DRUG

Interventions

Electrochemotherapy

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGEA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Filipponi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa Medical School Hospital, Pisa, Italy

Other Identifiers

PECTL1

Identifier Type: -

Identifier Source: org_study_id