Colorectal AdenocarcinomaPhase 1/2NCT02709811
Safety and Feasibility of Electrochemotherapy in Unresectable Colorectal Adenocarninoma Liver Metastases
A Phase 1/2 study testing Electrochemotherapy in people with Colorectal Adenocarcinoma, run by IGEA.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Electrochemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jan 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: Safety and Feasibility of Electrochemotherapy in the Treatment of Unresectable Liver Metastases From Colorectal Adenocarninoma
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
- Being tested
- Electrochemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrochemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| electrochemotherapy | Experimental | Not described Receives: Drug: Electrochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours from Electrochemotherapy treatment
Secondary outcomes (5)
Overall survival
Measured: 6 months from Electrochemotherapy treatment
Disease free survival
Measured: 6 months from Electrochemotherapy treatment
Quality of Life (Karnofsky performance status)
Measured: 30 days and 6 months from ECT treatment
Objective response evaluation of treated liver metastases following RECIST criteria
Measured: 30 days and 6 months from Electrochemotherapy treatment
Toxicity of Electrochemotherapy treatment of liver metastases as meaured by unexpected postoperative complications related to treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startAug 2012
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Enrollment at study center below rate compatible with study completion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGEA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franco Filipponi, MD, Principal investigator, University of Pisa Medical School Hospital, Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709811
- Sponsor's protocol ID
- PECTL1
- Status last verified
- Mar 2016
- First submitted
- 24 Nov 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Electrochemotherapy in the Treatment of Unresectable Liver Metastases From Colorectal Adenocarninoma
- ClinicalTrials.gov ID
- NCT02709811
- Acronym / sponsor ID
- PECTL1
- Conditions
- Colorectal Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment at study center below rate compatible with study completion.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IGEAIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrochemotherapy | Experimental | Drug: Electrochemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrochemotherapy | Drug | electrochemotherapy |
Primary outcome
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
Time frame: 24 hours from Electrochemotherapy treatment
Safety and feasibility evaluation of Electrochemotherapy treatment of liver metastases as meaured by unexpected intraoperative adverse events and related postoperative complications.
5 secondary outcomes
Overall survival
Time frame: 6 months from Electrochemotherapy treatment
Disease free survival
Time frame: 6 months from Electrochemotherapy treatment
Quality of Life (Karnofsky performance status)
Time frame: 30 days and 6 months from ECT treatment
Objective response evaluation of treated liver metastases following RECIST criteria
Time frame: 30 days and 6 months from Electrochemotherapy treatment
Toxicity of Electrochemotherapy treatment of liver metastases as meaured by unexpected postoperative complications related to treatment
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Enrollment at study center below rate compatible with study completion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Filipponi, MD principal investigator
University of Pisa Medical School Hospital, Pisa, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Electrochemotherapy in people with Colorectal Adenocarcinoma, run by IGEA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment at study center below rate compatible with study completion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 hours from Electrochemotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.