Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy
NCT ID: NCT00918593
Last Updated: 2011-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
98 participants
INTERVENTIONAL
2009-12-31
2014-02-28
Brief Summary
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Detailed Description
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With this study we wish to compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.
Patient recruitment: 98 patients are to be recruited, the patients will be randomized between electrochemothreapy or radiotherapy. 49 patients will be treated in each arm.
Treatment: Patients will be treated in local or general anesthesia (inhaling max. 30 % oxygen) Bleomycin will be given either intratumoral or intravenous. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5000 Hz or 1 Hz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.
The patients will be seen at 8, 30, 60, 90 and 180 days post treatment. Chest X ray will be taken before and after treatment for the patients receiving electrochemotherapy.
Evaluation: Evaluation is performed by measurement of lesion extension and digital photography using the RECIST criteria. The first 10 patients in each treatment arm will also be PET/CT-scanned before and one week after treatment.
Safety: Safety will be reported both in terms of evaluation of adverse events and in terms of patient satisfaction determined by questionnaire, including the 'Derriford Appearance Questionaire'.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Electrochemotherapy
Electrochemotherapy
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
Bleomycin
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
radiotherapy
Radiotherapy
Radiotherapy according to hospital procedures.
Interventions
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Electrochemotherapy
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
Radiotherapy
Radiotherapy according to hospital procedures.
Bleomycin
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Principal Investigators
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Julie Gehl, Consultant
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital at Herlev
Locations
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Copenhagen University Hospital at Herlev
Herlev, Copenhagen, Denmark
Countries
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Other Identifiers
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EudraCT number: 2009-011455-51
Identifier Type: -
Identifier Source: secondary_id
AA0906
Identifier Type: -
Identifier Source: org_study_id