Treatment of gynecological cancers with chemotherapy delivered locally to the tumor site by electrical pulses
| ISRCTN | ISRCTN16726595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16726595 |
| ClinicalTrials.gov number | NCT04760327 |
- Submission date
- 23/02/2020
- Registration date
- 26/02/2020
- Last edited
- 08/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
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
Contact information
Scientific
Institute of Oncology Ljubljana
Zaloska 2
Ljubljana
1000
Slovenia
 ORCID ID |
0000-0002-7641-5670 |
|---|---|
| Phone | +386-01-5879 434 |
| gsersa@onko-i.si |
Scientific
Institute of Oncology Ljubljana
Zaloska 2
Ljbubljana
1000
Slovenia
| ORCID ID |
0000-0002-1418-1928 |
|---|---|
| Phone | +386-01-5879 544 |
| mcemazar@onko-i.si |
Scientific
Institute of Oncology Ljubljana
Zaloska 2
Ljbubljana
1000
Slovenia
| ORCID ID |
0000-0001-7288-6582 |
|---|---|
| Phone | +386-01-5879 544 |
| mbosnjak@onko-i.si |
Study information
| Study design | Institutional interventional phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Electrochemotherapy of gynecological cancers |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 01/10/2017 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| 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 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
Study participating centre
Ljubljana
1000
Slovenia
Sponsor information
Hospital/treatment centre
Zaloska 2
Ljubljana
1000
Slovenia
| Phone | +386-01-5879 544 |
|---|---|
| mcemazar@onko-i.si | |
| Website | http://www.onko-i.si/ |
"ROR" |
https://ror.org/00y5zsg21 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Slovenian Research Agency, Javna agencija za raziskovalno dejavnost RS v angleškem jeziku: Slovenian Research Agency, Javna Agencija za Raziskovalno Dejavnost RS, The Slovenian Research and Innovation Agency (ARIS), Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije, ARRS, ARIS
- Location
- Slovenia
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Editorial Notes
08/04/2024: ClinicalTrials.gov number added.
26/02/2020: Trial’s existence confirmed by Republic of Slovenia National Medical Ethics Committee.
