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Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases

Primary Purpose

Colorectal Adenocarcinoma

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Electrochemotherapy

About this trial

This is an interventional treatment trial for Colorectal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

electrochemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

Disease free survival

Quality of Life (Karnofsky performance status)

Objective response evaluation of treated liver metastases following RECIST criteria

Toxicity of Electrochemotherapy treatment of liver metastases as meaured by unexpected postoperative complications related to treatment

Full Information

NCT ID

NCT02709811

First Posted

November 24, 2014

Last Updated

March 10, 2016

Sponsor

IGEA

1. Study Identification

Unique Protocol Identification Number

NCT02709811

Brief Title

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

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

Enrollment at study center below rate compatible with study completion.

Study Start Date

August 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IGEA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

electrochemotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Electrochemotherapy

Primary Outcome Measure Information:

Title

Description

Safety and feasibility evaluation of Electrochemotherapy treatment of liver metastases as meaured by unexpected intraoperative adverse events and related postoperative complications.

Time Frame

24 hours from Electrochemotherapy treatment

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

6 months from Electrochemotherapy treatment

Title

Disease free survival

Time Frame

6 months from Electrochemotherapy treatment

Title

Quality of Life (Karnofsky performance status)

Time Frame

30 days and 6 months from ECT treatment

Title

Objective response evaluation of treated liver metastases following RECIST criteria

Time Frame

30 days and 6 months from Electrochemotherapy treatment

Title

Toxicity of Electrochemotherapy treatment of liver metastases as meaured by unexpected postoperative complications related to treatment

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franco Filipponi, MD

Organizational Affiliation

University of Pisa Medical School Hospital, Pisa, Italy

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases

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