NCT06647342 The Effect of Reduced Bleomycin in Electrochemotherapy Treatment
| NCT ID | NCT06647342 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Julie Gehl |
| Condition | Cutaneous Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 55 participants in total. It began in 2024-10-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors. Electrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively. Participants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.
Eligibility Criteria
Inclusion Criteria: 1. Trial subject \> 18 years. 2. Trial subject must be able to understand the participant information. 3. Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. 4. Life expectancy \> 3 months. 5. Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study. 6. Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed. 7. Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed. 8. A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance \> 50 ml/min. 9. Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization. 10. Signed informed consent. Exclusion Criteria: 1. Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment. 2. Allergy or hypersensitivity to bleomycin. 3. Acute lung infection. 4. Severely impaired lung function or any lung condition the investigator deems severe. 5. Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit. 6. The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.
Contact & Investigator
Julie Gehl, Professor, MD
STUDY CHAIR
Department of Oncology and Palliative Care, Zealand University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT06647342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06647342 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06647342 currently recruiting?
Yes, NCT06647342 is actively recruiting participants. Contact the research team at kgeh@regionsjaelland.dk for enrollment information.
Where is the NCT06647342 trial being conducted?
This trial is being conducted at Herlev, Denmark, Roskilde, Denmark.
Who is sponsoring the NCT06647342 clinical trial?
NCT06647342 is sponsored by Julie Gehl. The principal investigator is Julie Gehl, Professor, MD at Department of Oncology and Palliative Care, Zealand University Hospital, Denmark. The trial plans to enroll 55 participants.