Treatment of gynecological cancers with chemotherapy delivered locally to the tumor site by electrical pulses

Not Applicable

• Conditions: Gynecologic cancer; Cancer

• Registration Number: ISRCTN16726595
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-26
• Last Update Posted: 22 April 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

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 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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