Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases

NCT02709811 | Terminated Phase 1

• 1 other identifier: PECTL1
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Overall survival

  6 months from Electrochemotherapy treatment

• Disease free survival

  6 months from Electrochemotherapy treatment

• Quality of Life (Karnofsky performance status)

  30 days and 6 months from ECT treatment

• Objective response evaluation of treated liver metastases following RECIST criteria

  30 days and 6 months from Electrochemotherapy treatment

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

  7 days

Study Arms (1)

electrochemotherapy

EXPERIMENTAL

Drug: Electrochemotherapy

Interventions

Electrochemotherapy DRUG

electrochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IGEA: lead

MeSH Terms

Interventions

Electrochemotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Franco Filipponi, MD

  University of Pisa Medical School Hospital, Pisa, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: March 16, 2016
• Study Start: August 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03