Treatment of soft tissue tumours through the skin using electrochemotherapy
- Conditions
- Soft tissue metastases in the soft tissue from any tumour histotype.CancerSoft tissue metastases
- Registration Number
- ISRCTN11667954
- Lead Sponsor
- Department of Surgical Oncological and Gastroenterological Sciences DISCOG, University of Padova
- Brief Summary
2020 results in: https://www.ncbi.nlm.nih.gov/pubmed/32042142 (added 12/02/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Cancer patients 18-year-old or older with locally-advanced or metastatic solid tumours of any histotypes
2. At least one measurable, well-demarcated soft tissue tumour (histologically proven) not amenable to surgical treatment and suitable for percutaneous electrode insertion
3. Tumour size has to be comprised between 3 cm and 7 cm, tumour depth between 3 cm and 20 cm
4. Patient performance status of = 2 according to the Eastern Cooperative Oncology Group (ECOG) scale
5. Agreement to local treatment with electrochemotherapy at the multidisciplinary team meeting
6. Signed informed consent
1. Clinically relevant lung disease, in particular, lung fibrosis
2. Severe heart, kidney or liver impairment
3. History of epilepsy
4. Short life expectancy (< 3 months)
5. Active infection
6. Previous treatment with bleomycin up to the maximal dosage (400,000 IU)
7. Concomitant local/systemic anticancer therapies administered within 4 weeks before and 8 weeks after ECT (unless agreed at the MDT meeting as being in the interest of the patient)
8. Clinically relevant abnormalities in coagulation tests
9. No infiltration of the target lesions across fascial planes at pre-operative radiological imaging (CT, MRI scan)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Antitumor activity (tumour response)assessed by Radiological (PET-CT and CT / MR scan) at baseline, 1 month, 2 months, then every 3 months<br> 2. Feasibility of the procedure (rate of procedures achieving tumour coverage with electric pulses) assessed by review of procedural data from the electric pulse generator at intraoperative (electric current flowed into the tumour) and postoperative (actual distribution of the electric field intensity around the target lesion)<br> 3. Safety assessed by clinical and anamnestic at baseline, intraoperative, at the conclusion of the procedure, during hospital stay (12h and/or 24h depending on discharge), and at every follow-up visit (1 week, 1, 2, 3, 6 months and every 3 months thereafter)<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Local control (local progression-free survival) assessed by clinical and radiological methods 3 months after treatment and every 3 months thereafter<br> 2. Patient-reported outcomes assessed by Health-related quality of life questionnaire (EQ-5D-3L) at baseline, 1 month, 2 months<br> 3. Improvement of the procedure assessed by study dedicated multidisciplinary audit meeting (including an anaesthetist, a surgeon, a radiologist and a medical engineer) aimed at discussing critical technical/clinical aspects, after every 3 performed procedures<br>