Soft tissue metastases in the soft tissue from any tumour histotype. Cancer Soft tissue metastases
Conditions
Interventions
Enrolled patients will be treated under regional/general anaesthesia or general sedation as appropriate according to tumour location and patient preference. They will receive the same dose of chemothe
Mir LM, Eur J Cancer Suppl. Nov 2016) The target tumour, instead, will be electroporated by means of the percutaneous insertion of 2-6 independent needle electrode probes connected with a dedicated pu
Sponsors
Department of Surgical Oncological and Gastroenterological Sciences DISCOG, University of Padova
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Antitumor activity (tumour response) assessed by Radiological (PET-CT and CT / MR scan) at baseline, 1 month, 2 months, then every 3 months 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) 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local control (local progression-free survival) assessed by clinical and radiological methods 3 months after treatment and every 3 months thereafter 2. Patient-reported outcomes assessed by Health-related quality of life questionnaire (EQ-5D-3L) at baseline, 1 month, 2 months 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 | — |
Countries
Italy
Outcome results
None listed