Clinical trial · Interventional
Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy
Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No recruitment of patients
Summary
Brief summary (as posted)
By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. The investigators wish compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ulcerated Cutaneous Metastases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Electrochemotherapy | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Electrochemotherapy
- interventionNames
- Drug: Electrochemotherapy
- Drug: Bleomycin
- type
- ACTIVE_COMPARATOR
- label
- radiotherapy
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Safety and response
- timeFrame
- 30 days
Secondary outcomes (2)
- measure
- patient satisfaction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18. * Histological proven cancer, any histology. * Progressive and/or metastatic disease. * One or more ulcerating cutaneous metastases. * Patient in need of palliation of the ulcerating metastases. * Lesion to be treated between 1 cm - 5 cm in diameter. * Lesions to be treated must be either stationary or progressing during any concomitant chemotherapy. * WHO performance ≤ 2. * Life expectancy of at least 3 months. * Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed. * Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment. * Written informed consent must be obtained according to the local Ethics committee requirements. Exclusion Criteria: * Previous electrochemotherapy or radiotherapy in the area to be treated * Acute lung infection * Previous bleomycin treatment exceeding 200.000 Units/m2. * Known hypersensitivity to any of the components of the treatment. * Known hypersensitivity to any of the components used in the planned anaesthesia. * Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood. * Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines. * Creatinine measurements over 150 micromolar will require Crohm-EDTA clearance. Crohm-EDTA below 48 ml/minute * Abnormal DLCO. If clinical history of or suspected reduced lung capacity, DLCO must be performed.
References
Publications (0)
Data not yet available