Condition category
Cancer
Date applied
23/02/2020
Date assigned
26/02/2020
Last edited
26/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of local or regional recurrences of gynecologic tumors in which standard treatment has been exhausted.

Who can participate?
Patients with local or regional recurrences of gynecologic tumors in which standard treatment has been exhausted.

What does the study involve?
All participants will be treated with electrochemotherapy. The procedure is standardized and is performed according to the published Standard Operating Procedure (SOP) for electrochemotherapy. The chemotherapy drug bleomycin is injected intravenously or intratumorally and cisplatin only intratumorally. Electric pulses will be delivered to the tumour in order to facilitate the entrance of chemotherapeutic drug into the cancer cells.

What are the possible benefits and risks of participating?
So far minimal or no side effects have been reported. Due to the pain caused by the electric
pulses, local or general anaesthesia will be needed. There may be some reddening of the skin but no pain after the treatment is complete is expected.

Where is the study run from?
Institute of Oncology Ljubljana (Slovenia)

When is the study starting and how long is it expected to run for?
April 2020 to December 2025

Who is funding the study?
Slovenian Research Agency, ARRS (Javna Agencija za Raziskovalno Dejavnost RS)

Who is the main contact?
Prof. Gregor Sersa
gsersa@onko-i.si
Prof. Maja Cemazar
mcemazar@onko-i.si

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gregor Sersa

ORCID ID

http://orcid.org/0000-0002-7641-5670

Contact details

Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
+386-01-5879 434
gsersa@onko-i.si

Type

Scientific

Additional contact

Prof Maja Cemazar

ORCID ID

http://orcid.org/0000-0002-1418-1928

Contact details

Institute of Oncology Ljubljana
Zaloska 2
Ljbubljana
1000
Slovenia
+386-01-5879 544
mcemazar@onko-i.si

Type

Scientific

Additional contact

Mr Maša Bošnjak

ORCID ID

http://orcid.org/0000-0001-7288-6582

Contact details

Institute of Oncology Ljubljana
Zaloska 2
Ljbubljana
1000
Slovenia
+386-01-5879 544
mbosnjak@onko-i.si

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Electrochemotherapy of gynecological cancers

Acronym

GynECT

Study hypothesis

Electrochemotherapy can be used to achieve local/regional tumor control and palliation of gynecologic tumors where standard treatment has been exhausted.

Ethics approval

Approved 27/1/2018, Republic of Slovenia National Medical Ethics Committee (Ministry of Health, Štefanova 5, SI-1000 Ljubljana, Slovenia; +386 1 478 69 13; kme.mz@gov.si), ref: 0120-692/2017/4

Study design

Institutional interventional phase II study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Gynecologic cancer

Intervention

Patients will be treated with electrochemotherapy according to Standard Operating Procedure (SOP) for electrochemotherapy. Intravenous or intratumoral bleomycin or intratumoral cisplatin will be used as described in SOP. The electric pulses will be delivered by electrodes to the tumors generated by electric pulse generator Cliniporator (IGEA, Carpi, Italy).

One time treatment, maximal duration of the procedure 30 minutes.

Follow up: 1, 3, 6, 9, 12,18, and 24 months after the electrochemotherapy.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Effectiveness will be measured by determined tumor volume according to RECIST (version 1.1) before the therapy and at each follow up: 1, 3, 6, 9, 12, 18, and 24 months after the therapy

Secondary outcome measures

Safety will be followed at each follow-up visit: 1, 3, 6, 9, 12, 18, and 24 months after the therapy, according to CTCAE criteria

Overall trial start date

01/10/2017

Overall trial end date

31/12/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Local or regional recurrences of gynecologic tumors in which standard treatment has been exhausted
2. Age over 18 years
3. Life expectancy of more than 3 months
4. Karnofsky body capacity ≥ 70 or <or 2 based on the WHO scale
5. At least 2 weeks have elapsed since the last possible treatment
6. The patient should be able to understand the treatment process and any side effects that may occur with the treatment
7. The patient must be able to sign inform consent to participate in the clinical study
8. Before entering the study, the patient must be presented at the multidisciplinary board
9. Suitable for procedures in anesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Lesions not suitable for treatment with electrochemotherapy (invasion of bone, infiltration of large vessels)
2. A life-threatening infection and/or heart failure and/or liver failure and/or other threatening systemic diseases
3. A significant decline in lung function that requires DLCO determination. We are not allowed to treat patients if DLCO is abnormal
4. Age under 18 years
5. Major disruptions in the coagulation system (which do not respond to the standard therapy – supplementation of vitamin K or freshly frozen plasma)
6. A previously received cumulative dose of bleomycin≥ 400 mg / m²
7. A chronic decline in the kidney function (creatinine > 150 µmol/L)
8. Epilepsy
9. Pregnancy
10. The patients’ uncapatibily of comprehending the purpose or course of the trial, or not agreeing to be included in the trial

Recruitment start date

01/04/2020

Recruitment end date

01/07/2025

Locations

Countries of recruitment

Slovenia

Trial participating centre

Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Institute of Oncology Ljubljana

Sponsor details

Zaloska 2
Ljubljana
1000
Slovenia
+386-01-5879 544
mcemazar@onko-i.si

Sponsor type

Hospital/treatment centre

Website

http://www.onko-i.si/

Funders

Funder type

Government

Funder name

Javna Agencija za Raziskovalno Dejavnost RS

Alternative name(s)

Slovenian Research Agency, ARRS

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Slovenia

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Intention to publish date

31/12/2026

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/02/2020: Trial’s existence confirmed by Republic of Slovenia National Medical Ethics Committee.