E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerated cutaneous metastases from solid tumor cancers is a particularly difficult problem with painful skin ulceration, maladorous discharge and bleeding. The intention of this study is to investigate the best palliative treatment to this group of patients. Electrochemotherapy (enhanced local uptake of bleomycin by the use of electric pulses) has proven efficient. We wish to compare electrochemotherapy with radiotherapy in the palliative setting for this patient group. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040892 |
E.1.2 | Term | Skin metastases |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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E.2.2 | Secondary objectives of the trial |
Safety and toxicity of the treatment. Quality of life. Patient time spend in hospital and transport Health economy.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Histological analysis. Time to PET image response
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E.3 | Principal inclusion criteria |
1) Age ≥ 18 years 2) Histological proven cancer 3) Progressive and/or metastatic disease 4) One or more ulcerated cutaneous lessions 5) Patient need for palliative tretment for the cutaneous lession(s) 6) Target lession ≥ 1 cm and ≤ 5 cm, max 5 target lessions 7) The cutaneous lession(s) must be stationary or progressive if the patient at the same time is treated with chemotherapy. 8) WHO performancestatus ≤ 2 9) Life expectancy ≥3 months 10) Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is alloved. 11) Sexually active men and women in the reproductive age must use safe anticonception during and up to 6 months after treatment. 12) Written informed consent must be obtained according to the local Ethics Commitee requirements. |
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E.4 | Principal exclusion criteria |
1) Previous electrochemotherapy or radiotherapy of the target area 2) Acute lunginfection 3) Previous bleomycin treatment exceeding 200.000 Units/m2 4) Known hypersensitivity to any of the components of the treatment 5) Known hypersensitivity to any of the components used in the planned anaesthesia 6) Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood. 7) Treatment with granulocyt colony stimulating factor (G-CSF) or other cytokines. 8) If creatinin is over 150 mikromolær, glomerular filtration rate must be investigated by Crom-EDTA-clearance. If Crom-EDTA-clearance < 48 ml/min the patient can not be offered treatment in the protocol. 9) Lungdiffusion kapacity (DLCO test) under the normal area. DLCO test is carried out if clinical or anamnestic suspicion of reduced lungkapacity. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Response rate Safety and toxicity of the treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
body image (questionaire) |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |