Colorectal CancerPhase 1CCEE EndoVeNCT01172860
Endoscopic Treatment of Inoperable Colorectal Cancer With the EndoVe System
A Phase 1 study testing EndoVe endoscopic electroporation in people with Colorectal Cancer, run by Mercy University Hospital, Cork, Ireland at 1 site in Ireland.
Trial summary
A new approach to treating solid tumours (both operable and inoperable) has been carried out by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland since 2002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- EndoVe endoscopic electroporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2010to Sep 2016
- Phase
- Phase 1
- 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
- Histologically verified colorectal tumour.
- Case reviewed by a multidisciplinary team (MDT) (surgery, radiology, oncology, gastroenterology) and there are no curable options with the standard of care. The MDT considers all available treatment options and enrolment to this study is agreed as being appropriate; Or the case is curable but patient refuses to undergo the standard of care. The MDT considers all possible alternatives, which are also discussed with the patient, and the MDT considers enrolment to this study as being the most appropriate option; Or patients with advanced local disease with impending obstruction on endoscopic evaluation who are otherwise not suitable for surgical intervention or stenting, the MDT would also consider these patients for enrolment into this study.
- Men or women aged at least 18 years.
- Performance status (Karnofsky > 60% or ECOG/WHO < 2).
- Treatment free interval of at least 2 weeks after previously applied therapy.
- Patients must be mentally capable of understanding the information given.
Show all 11Show fewer
- Patients must give written informed consent.
- a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
- has had a hysterectomy
- has had a bilateral oophorectomy (ovariectomy) - has had a bilateral tubal ligation
- Is post-menopausal:
Who cannot join
- Coagulation disorder
- Patients with pre-existing renal dysfunction are excluded. [Note: Creatinine clearance will be measured for all patients. For Bleomycin treatment: creatinine clearance must be greater than 40ml/min.]
- Patients with a clinically manifested arrhythmia or with a pacemaker
- Patients with epilepsy.
- Pregnancy or lactation/breastfeeding.
- Patient known to be Hepatitis B/C or HIV positive.
Show all 23Show fewer
- Concurrent treatment with an investigational medicinal product or participation in another clinical study.
- Patients who have undergone a regime of Bevacizumab in the previous 4 weeks.
- Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
- Highly inflamed colon tissue which is ulcerated and bleeding.
- Additional exclusion criteria specifically regarding patients where Bleomycin is study drug:
- Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.
- Contraindication for bleomycin use: allergic reactions to bleomycin observed in previous treatment.
- Contraindication for bleomycin use: if cumulative dose of 250mg BLM/m2 was previously exceeded.
- Additional exclusion criteria specifically regarding patients where Cisplatin is study drug:
- Patients with hypersensitivity to Cisplatin or other platinum compounds or to any of the excipients are to be excluded from receiving Cisplatin for the study.
- Cisplatin is contraindicated in combination with live vaccines, including yellow fever vaccine.
- Cisplatin is contraindicated in combination with phenytoin in prophylactic use.
- Cisplatin is contraindicated in patients with myelosuppression.
- Cisplatin is contraindicated in patients in a dehydrated condition (pre- and post-hydration is required to prevent serious renal dysfunction).
- Cisplatin is contraindicated in patients with a pre-existing hearing impairment.
- Cisplatin is contraindicated in patients with neuropathy caused by cisplatin.
- Contraindication for Cisplatin use: Allergic reactions to Cisplatin observed in previous treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Inoperable Colorectal Cancer With Electrochemotherapy Through an Endoscopic System
A new approach to treating solid tumours (both operable and inoperable) has been carried out by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland since 2002.
The approach simply allows a greater concentration of chemotherapy drugs to enter the tumour cells rather than healthy cells. The uptake of the chemotherapeutic drug directly by the tumour is aided through applying short electric pulses to the tumor mass (referred to as - Electrochemotherapy or ECT). The pulses make the tumour more porous which allows the drug easier access into the cancer cells, whereas other tissues and organs in the body remain relatively poor at absorbing the drug, thereby reducing the potential side effects on healthy tissues. This approach to date has been limited to skin based tumours due to the requirement for the electrodes to be placed directly in contact with the tumour. Procedures with electrochemotherapy have been applied to human patients in other countries of the EU, the US and Japan.
Read more
The drug concentration used is significantly reduced due to the more targeted absorption by the tumor and this significantly reduces side effects normally associated with chemotherapy.
A large number of preclinical and clinical Phase I and I/II studies have demonstrated the efficiency and safety of ECT. These studies have included patients with melanoma, head and neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and adenocarcinoma nodules. Case reports concerning other primary tumours have also been reported.
The investigators have developed an endoscopic approach (EndoVe system) for delivering the electric pulses to internal cancers and are currently seeking to evaluate its efficacy in the treatment of inoperable colorectal cancer. The treatment procedure is similar to standard endoscopic colorectal examination (colonoscopy) with the added element of an intravenous injection of bleomycin followed after eight minutes by the delivery of electric pulses (each one less than 1msec in duration). The pulses are endoscopically delivered directly to the tumour mass. The entire procedure is minimally invasive and does not require intensive care follow up or stitches. If the treatment is successful the tumour will shrink in size in the weeks following the procedure.
The objective of this study is to investigate the efficacy and safety of this approach in reducing the size of the tumour.
Read the detailed description
The objective is to conduct treatment in a minimally invasive manner (using the endoscope) and without the requirement for repeated doses of chemotherapy. The single dose of the drug used (15,000 IU/m2 x Body Surface Area of bleomycin) has been well tolerated in all patients treated previously with this approach to skin based cancers (in excess of 300 treatments since 2003 in our hospital). Therefore, it is anticipated that patients are unlikely to suffer side effects from the low concentration of drug used.
There are no known side effects of the instrument being tested. The pulse generator used has been certified by European electrical safety bodies charged with assessing compliance of new equipment with the present security rules for electrical devices. The electrical pulse generator has the CE mark and is approved for use clinically; the endoscopic electrodes used are a prototype system and are not currently CE approved.
The treatment is provided on an outpatient basis and does not involve an overnight stay. The procedure is very similar to a colonoscopy examination with the added element of a low dose chemotherapy drug being injected intravenously.
It reduces operative time; therefore there are fewer anaesthetic risks
At this time, the only option for patients with inoperable colorectal cancers is symptom relief e.g. a defunctioning colostomy or stent placement. Both carry a risk profile greater than the treatment with the EndoVe system.
Quicker recovery time- This is beneficial for the patient in terms of reduced exposure to the hospital environment through a shorter in-patient stay.
Research: The potential benefits of studying novel medical instruments in general include the development of new alternatives to conventional or existing therapies for certain cancers. In particular, the widespread availability of the novel instrument being tested here may lessen the requirement for more invasive procedures. It will reduce the amount of chemotherapy drug being used, therefore reducing the systemic effects as well as the side effects.
The approach is currently being applied to inoperable cases but in the future it may potentially be applied to both earlier stage cancers and other internal cancers e.g. oesophagus, stomach etc.
Because the treatment procedure is short (outpatient basis), it allows these patients greater time outside of the hospital environment to maximise and allowing for a greater quality of life (this for both individual patient and community at large).
If this treatment approach is proven to be safe and effective, patients with inoperable colorectal cancers will have a minimally invasive option for palliation of symptoms.
- Conditions
- Colorectal Cancer
- Being tested
- EndoVe endoscopic electroporation
- Keywords
- Inoperable, Colorectal, Endoscopic, Electroporation, Outpatient
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoVe endoscopic electroporationDevice
Also called EndoVe, Endoscope
The EndoVe device enables the endoscopic treatment of gastrointestinal tumor tissues. The device is placed on the tumor tissue and an electrical pulse of less than 1msec is delivered. The tumor tissue becomes permeabilised and absorbs much greater concentrations of the drug than the surrounding healthy tissue
| Study group | Role | What they receive |
|---|---|---|
| EndoVe treatment | Experimental | Use of the EndoVe device to safely and effectively ablate rectal tumor tissue Receives: Device: EndoVe endoscopic electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor regression
Follow up examination of tumor volume following treatment via endoscopy and transrectal ultrasound.
Measured: 3 months
treatment safety
Evaluate safety of treatment approach at regular checkup intervals following treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy University Hospital, Cork, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- St. James's Hospital, Ireland, The Adelaide and Meath Hospital
- Responsible party
- Principal investigator, Dr Declan Soden, Mercy University Hospital, Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172860
- Sponsor's protocol ID
- EudraCT:2012-001248-23
- Acronym
- CCEE EndoVe
- Status last verified
- Nov 2017
- First submitted
- 29 Jul 2010
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gargiulo M, Moio M, Monda G, Parascandolo S, Cubicciotti G. Electrochemotherapy: actual considerations and clinical experience in head and neck cancers. Ann Surg. 2010 Apr;251(4):773. doi: 10.1097/SLA.0b013e3181d64b81. No abstract available.
PubMed 20375711Moller MG, Salwa S, Soden DM, O'Sullivan GC. Electrochemotherapy as an adjunct or alternative to other treatments for unresectable or in-transit melanoma. Expert Rev Anticancer Ther. 2009 Nov;9(11):1611-30. doi: 10.1586/era.09.129.
PubMed 19895245Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, Vecchiato A, Corti L, Rossi CR, Nitti D. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol. 2009 Jan;16(1):191-9. doi: 10.1245/s10434-008-0204-8. Epub 2008 Nov 6.
PubMed 18987914Quaglino P, Mortera C, Osella-Abate S, Barberis M, Illengo M, Rissone M, Savoia P, Bernengo MG. Electrochemotherapy with intravenous bleomycin in the local treatment of skin melanoma metastases. Ann Surg Oncol. 2008 Aug;15(8):2215-22. doi: 10.1245/s10434-008-9976-0. Epub 2008 May 23.
PubMed 18498012Sadadcharam M, Soden DM, O'sullivan GC. Electrochemotherapy: an emerging cancer treatment. Int J Hyperthermia. 2008 May;24(3):263-73. doi: 10.1080/02656730701832334.
PubMed 18393004Larkin JO, Collins CG, Aarons S, Tangney M, Whelan M, O'Reily S, Breathnach O, Soden DM, O'Sullivan GC. Electrochemotherapy: aspects of preclinical development and early clinical experience. Ann Surg. 2007 Mar;245(3):469-79. doi: 10.1097/01.sla.0000250419.36053.33.
PubMed 17435555Mir LM, Morsli N, Garbay JR, Billard V, Robert C, Marty M. Electrochemotherapy: a new treatment of solid tumors. J Exp Clin Cancer Res. 2003 Dec;22(4 Suppl):145-8.
PubMed 16767921Byrne CM, Thompson JF. Role of electrochemotherapy in the treatment of metastatic melanoma and other metastatic and primary skin tumors. Expert Rev Anticancer Ther. 2006 May;6(5):671-8. doi: 10.1586/14737140.6.5.671.
PubMed 16759159Soden DM, Larkin JO, Collins CG, Tangney M, Aarons S, Piggott J, Morrissey A, Dunne C, O'Sullivan GC. Successful application of targeted electrochemotherapy using novel flexible electrodes and low dose bleomycin to solid tumours. Cancer Lett. 2006 Feb 8;232(2):300-10. doi: 10.1016/j.canlet.2005.03.057. Epub 2005 Jun 16.
PubMed 15964138Snoj M, Rudolf Z, Cemazar M, Jancar B, Sersa G. Successful sphincter-saving treatment of anorectal malignant melanoma with electrochemotherapy, local excision and adjuvant brachytherapy. Anticancer Drugs. 2005 Mar;16(3):345-8. doi: 10.1097/00001813-200503000-00015.
PubMed 15711188
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Inoperable Colorectal Cancer With Electrochemotherapy Through an Endoscopic System
- ClinicalTrials.gov ID
- NCT01172860
- Acronym / sponsor ID
- CCEE EndoVe / EudraCT:2012-001248-23
- Conditions
- Colorectal Cancer
- Keywords
- Inoperable, Colorectal, Endoscopic, Electroporation, Outpatient
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mercy University Hospital, Cork, IrelandUniversity, hospital or other
- Collaborators
- St. James's Hospital, Ireland, The Adelaide and Meath Hospital
- Study start
- Mar 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Jul 2010 (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.
A new approach to treating solid tumours (both operable and inoperable) has been carried out by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland since 2002.
The approach simply allows a greater concentration of chemotherapy drugs to enter the tumour cells rather than healthy cells. The uptake of the chemotherapeutic drug directly by the tumour is aided through applying short electric pulses to the tumor mass (referred to as - Electrochemotherapy or ECT). The pulses make the tumour more porous which allows the drug easier access into the cancer cells, whereas other tissues and organs in the body remain relatively poor at absorbing the drug, thereby reducing the potential side effects on healthy tissues. This approach to date has been limited to skin based tumours due to the requirement for the electrodes to be placed directly in contact with the tumour. Procedures with electrochemotherapy have been applied to human patients in other countries of the EU, the US and Japan.
The drug concentration used is significantly reduced due to the more targeted absorption by the tumor and this significantly reduces side effects normally associated with chemotherapy.
A large number of preclinical and clinical Phase I and I/II studies have demonstrated the efficiency and safety of ECT. These studies have included patients with melanoma, head and neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and adenocarcinoma nodules. Case reports concerning other primary tumours have also been reported.
The investigators have developed an endoscopic approach (EndoVe system) for delivering the electric pulses to internal cancers and are currently seeking to evaluate its efficacy in the treatment of inoperable colorectal cancer. The treatment procedure is similar to standard endoscopic colorectal examination (colonoscopy) with the added element of an intravenous injection of bleomycin followed after eight minutes by the delivery of electric pulses (each one less than 1msec in duration). The pulses are endoscopically delivered directly to the tumour mass. The entire procedure is minimally invasive and does not require intensive care follow up or stitches. If the treatment is successful the tumour will shrink in size in the weeks following the procedure.
The objective of this study is to investigate the efficacy and safety of this approach in reducing the size of the tumour.
Detailed description
The objective is to conduct treatment in a minimally invasive manner (using the endoscope) and without the requirement for repeated doses of chemotherapy. The single dose of the drug used (15,000 IU/m2 x Body Surface Area of bleomycin) has been well tolerated in all patients treated previously with this approach to skin based cancers (in excess of 300 treatments since 2003 in our hospital). Therefore, it is anticipated that patients are unlikely to suffer side effects from the low concentration of drug used.
There are no known side effects of the instrument being tested. The pulse generator used has been certified by European electrical safety bodies charged with assessing compliance of new equipment with the present security rules for electrical devices. The electrical pulse generator has the CE mark and is approved for use clinically; the endoscopic electrodes used are a prototype system and are not currently CE approved.
The treatment is provided on an outpatient basis and does not involve an overnight stay. The procedure is very similar to a colonoscopy examination with the added element of a low dose chemotherapy drug being injected intravenously.
It reduces operative time; therefore there are fewer anaesthetic risks
At this time, the only option for patients with inoperable colorectal cancers is symptom relief e.g. a defunctioning colostomy or stent placement. Both carry a risk profile greater than the treatment with the EndoVe system.
Quicker recovery time- This is beneficial for the patient in terms of reduced exposure to the hospital environment through a shorter in-patient stay.
Research: The potential benefits of studying novel medical instruments in general include the development of new alternatives to conventional or existing therapies for certain cancers. In particular, the widespread availability of the novel instrument being tested here may lessen the requirement for more invasive procedures. It will reduce the amount of chemotherapy drug being used, therefore reducing the systemic effects as well as the side effects.
The approach is currently being applied to inoperable cases but in the future it may potentially be applied to both earlier stage cancers and other internal cancers e.g. oesophagus, stomach etc.
Because the treatment procedure is short (outpatient basis), it allows these patients greater time outside of the hospital environment to maximise and allowing for a greater quality of life (this for both individual patient and community at large).
If this treatment approach is proven to be safe and effective, patients with inoperable colorectal cancers will have a minimally invasive option for palliation of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoVe treatment | Experimental | Device: EndoVe endoscopic electroporationUse of the EndoVe device to safely and effectively ablate rectal tumor tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically verified colorectal tumour.
- Case reviewed by a multidisciplinary team (MDT) (surgery, radiology, oncology, gastroenterology) and there are no curable options with the standard of care. The MDT considers all available treatment options and enrolment to this study is agreed as being appropriate; Or the case is curable but patient refuses to undergo the standard of care. The MDT considers all possible alternatives, which are also discussed with the patient, and the MDT considers enrolment to this study as being the most appropriate option; Or patients with advanced local disease with impending obstruction on endoscopic evaluation who are otherwise not suitable for surgical intervention or stenting, the MDT would also consider these patients for enrolment into this study.
- Men or women aged at least 18 years.
- Performance status (Karnofsky > 60% or ECOG/WHO < 2).
- Treatment free interval of at least 2 weeks after previously applied therapy.
Key exclusion criteria (23 listed)
- Coagulation disorder
- Patients with pre-existing renal dysfunction are excluded. [Note: Creatinine clearance will be measured for all patients. For Bleomycin treatment: creatinine clearance must be greater than 40ml/min.]
- Patients with a clinically manifested arrhythmia or with a pacemaker
- Patients with epilepsy.
- Pregnancy or lactation/breastfeeding.
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 |
|---|---|---|
| EndoVe endoscopic electroporationAlso: EndoVe, EndoscopeThe EndoVe device enables the endoscopic treatment of gastrointestinal tumor tissues. The device is placed on the tumor tissue and an electrical pulse of less than 1msec is delivered. The tumor tissue becomes permeabilised and absorbs much greater concentrations of the drug than the surrounding healthy tissue | Device | EndoVe treatment |
Primary outcome
Tumor regression
Time frame: 3 months
Follow up examination of tumor volume following treatment via endoscopy and transrectal ultrasound.
treatment safety
Time frame: 3 months
Evaluate safety of treatment approach at regular checkup intervals following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Background: PubMed 20375711Gargiulo M, Moio M, Monda G, Parascandolo S, Cubicciotti G. Electrochemotherapy: actual considerations and clinical experience in head and neck cancers. Ann Surg. 2010 Apr;251(4):773. doi: 10.1097/SLA.0b013e3181d64b81. No abstract available.
- Background: PubMed 19895245Moller MG, Salwa S, Soden DM, O'Sullivan GC. Electrochemotherapy as an adjunct or alternative to other treatments for unresectable or in-transit melanoma. Expert Rev Anticancer Ther. 2009 Nov;9(11):1611-30. doi: 10.1586/era.09.129.
- Background: PubMed 18987914Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, Vecchiato A, Corti L, Rossi CR, Nitti D. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol. 2009 Jan;16(1):191-9. doi: 10.1245/s10434-008-0204-8. Epub 2008 Nov 6.
- Background: PubMed 18498012Quaglino P, Mortera C, Osella-Abate S, Barberis M, Illengo M, Rissone M, Savoia P, Bernengo MG. Electrochemotherapy with intravenous bleomycin in the local treatment of skin melanoma metastases. Ann Surg Oncol. 2008 Aug;15(8):2215-22. doi: 10.1245/s10434-008-9976-0. Epub 2008 May 23.
- Background: PubMed 18393004Sadadcharam M, Soden DM, O'sullivan GC. Electrochemotherapy: an emerging cancer treatment. Int J Hyperthermia. 2008 May;24(3):263-73. doi: 10.1080/02656730701832334.
- Background: PubMed 17435555Larkin JO, Collins CG, Aarons S, Tangney M, Whelan M, O'Reily S, Breathnach O, Soden DM, O'Sullivan GC. Electrochemotherapy: aspects of preclinical development and early clinical experience. Ann Surg. 2007 Mar;245(3):469-79. doi: 10.1097/01.sla.0000250419.36053.33.
- Background: PubMed 16767921Mir LM, Morsli N, Garbay JR, Billard V, Robert C, Marty M. Electrochemotherapy: a new treatment of solid tumors. J Exp Clin Cancer Res. 2003 Dec;22(4 Suppl):145-8.
- Background: PubMed 16759159Byrne CM, Thompson JF. Role of electrochemotherapy in the treatment of metastatic melanoma and other metastatic and primary skin tumors. Expert Rev Anticancer Ther. 2006 May;6(5):671-8. doi: 10.1586/14737140.6.5.671.
- Background: PubMed 15964138Soden DM, Larkin JO, Collins CG, Tangney M, Aarons S, Piggott J, Morrissey A, Dunne C, O'Sullivan GC. Successful application of targeted electrochemotherapy using novel flexible electrodes and low dose bleomycin to solid tumours. Cancer Lett. 2006 Feb 8;232(2):300-10. doi: 10.1016/j.canlet.2005.03.057. Epub 2005 Jun 16.
- Background: PubMed 15711188Snoj M, Rudolf Z, Cemazar M, Jancar B, Sersa G. Successful sphincter-saving treatment of anorectal malignant melanoma with electrochemotherapy, local excision and adjuvant brachytherapy. Anticancer Drugs. 2005 Mar;16(3):345-8. doi: 10.1097/00001813-200503000-00015.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EndoVe endoscopic electroporation in people with Colorectal Cancer, run by Mercy University Hospital, Cork, Ireland at 1 site in Ireland.
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 11 inclusion and 23 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: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor regression (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172860, which also lists 10 linked publications.
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 9 Nov 2017.