Electrochemotherapy in basal cell carcinoma

Not Applicable

Completed

• Conditions: Basal cell carcinoma (any type): local, locally-advanced, metastatic; Cancer

• Registration Number: ISRCTN14633165
• Lead Sponsor: Veneto Institute of Oncology IOv-IRCCS

Brief Summary

2017 results in https://pubmed.ncbi.nlm.nih.gov/28569161/ (added 26/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-03-10
• Study Start: 2017-03-24
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Aged 18 years or older
2. Cutaneous / subcutaneous histologically confirmed skin metastases or primary or recurrent basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
3. Measurable disease
4. Unresponsive or unsuitable for conventional treatments
5. In case of local BCC, the patients have to present with =2 tumors when located in the face or with =3 tumors when located in other anatomical regions
6. Patients with laBCC had at least one lesion >2 cm or any size plus ?2 risk features so that surgical resection was deemed inappropriate; moreover, laBCC have to be previously irradiated or, alternatively, radiation therapy have to be considered contraindicated or inappropriate (e.g. multifocal disease)
7. All subject have to be discussed in the frame of a multidisciplinary team
8. Tumor size smaller than 3 cm in thickness
9. Tumor not deeper than 3 cm
10. No concomitant treatments one month before and two months following ECT
11. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
12. Life expectancy of at least three months
13. Normal hematologic, hepatic and renal function

Exclusion Criteria

1. Abnormal respiratory function
2. A cardiac pacemaker or arrhythmias
3. Previous maximal exposure to bleomycin
4. History of seizures

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Local tumor response is clinically measured using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at one and two months<br> 2. Treatment toxicity is measured by means of clinical examination and graded by using the Common Terminology Criteria for Adverse Events (CTCAE) criteria at the end of the procedure, during the hospital stay (indicatively at 4:00 pm of the day of treatment and 8:00 am of the following day), week one, one, two, six and 12 months after surgery and every six to 12 months thereafter<br>

Secondary Outcome Measures

Name	Time	Method
ocal tumor control is assessed by inspection of the skin at six and 12 months after ECT and on a six to 12-month basis thereafter.