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Phase I Study for the Minimally Invasive Endoscopic Treatment of Inoperable Colorectal Cancer With Electrochemotherapy

Phase 1
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Phase I Study for the Minimally Invasive Endoscopic Treatment of Inoperable Colorectal Cancer With Electrochemotherapy

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

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.

Inclusion Criteria:

- Histologically verified colorectal tumour.

- Progressive and/or metastatic disease.

- Tumour defined as inoperable by patient's consultant surgeon and / or oncologist.

- Patients must have been offered standard treatments according to the policies in
their country of residence. Electrochemotherapy can be considered either in case of
progression after standard treatments or in case the patient has not wished to
receive such standard treatment.

- Age at least 18 years.

- Performance status (Karnofsky ≥ 70 OR WHO < 2).

- Life expectancy of at least 3 months.

- Treatment free interval of at least 2 weeks after previously applied therapy.

- Patients must be mentally capable of understanding the information given.

- Patients must give informed consent.

Exclusion Criteria:

- Coagulation disorder

- Contraindications for bleomycin use include acute pulmonary infection and severe
pulmonary disease.

- Allergic reactions to bleomycin observed in previous treatment

- If cumulative dose of 250mg BLM/m2 was previously exceeded

- Chronic renal dysfunction (creatinine clearance < 50 ml/min)

- Patients with a clinically manifested arrhythmia or with a pacemaker

- Patients with epilepsy.

- Pregnancy or lactation.

- Patient known to be Hepatitis B/C or HIV positive.

Type of Study:


Study Design:

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

Outcome Measure:

Tumor regression

Outcome Description:

Follow up examination of tumor volume following treatment via endoscopy and transrectal ultrasound.

Outcome Time Frame:

3 months

Safety Issue:



Ireland: Irish Medicines Board

Study ID:




Start Date:

November 2009

Completion Date:

October 2012

Related Keywords:

  • Colorectal Cancer
  • Inoperable
  • Colorectal
  • Endoscopic
  • Electroporation
  • Outpatient
  • Colorectal Neoplasms