Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
18 Years
N/A
Both
Ulcerated Cutaneous Metastases
Trial Information
Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
About 5 % of all cancer patients experience cutaneous metastases. Ulcerating metastases can
be of great psychological distress for the patients and may also be painful. Radiation
therapy is standard treatment for ulcerating metastases, but there are no reports of
response rate.
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'.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and response
Outcome Time Frame:
30 days
Safety Issue:
Yes
Principal Investigator
Julie Gehl, Consultant
Investigator Role:
Principal Investigator
Investigator Affiliation:
Copenhagen University Hospital at Herlev
Authority:
Denmark: Ethics Committee and the Danish Medicines Agency
Study ID:
AA0906
NCT ID:
NCT00918593
Start Date:
December 2009
Completion Date:
February 2014
Related Keywords:
- Ulcerated Cutaneous Metastases
- Metastases
- Cutaneous
- Ulcerating
- Palliative
- ulcerating metastases
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Ulcer
- Skin Neoplasms
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