Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases

Colorectal Adenocarcinoma Clinical Trial

Official title:

Safety and Feasibility of Electrochemotherapy in the Treatment of Unresectable Liver Metastases From Colorectal Adenocarninoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02709811
• Other study ID #: PECTL1
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 24, 2014
• Last updated: March 10, 2016
• Start date: August 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2016
• Source: IGEA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma

Intervention

Drug:
• Electrochemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IGEA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and feasibility evaluation of Electrochemotherapy treatment of liver metastases as meaured by unexpected intraoperative adverse events and related postoperative complications.	24 hours from Electrochemotherapy treatment	Yes
Secondary	Overall survival		6 months from Electrochemotherapy treatment	No
Secondary	Disease free survival		6 months from Electrochemotherapy treatment	No
Secondary	Quality of Life (Karnofsky performance status)		30 days and 6 months from ECT treatment	No
Secondary	Objective response evaluation of treated liver metastases following RECIST criteria		30 days and 6 months from Electrochemotherapy treatment	No
Secondary	Toxicity of Electrochemotherapy treatment of liver metastases as meaured by unexpected postoperative complications related to treatment		7 days	No