Electrochemotherapy compaired with radiotherapy for the treatment of basal cell carcinoma

Electrochemotherapy versus standard radiatiotherapy for the treatment of basal cell carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002255-25-DK

Enrollment

Registered

2016-06-30

Start date

2016-09-12

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients suffering from basal cell carcinoma MedDRA version: 21.0 Level: LLT Classification code 10073090 Term: Keratotic basal cell carcinoma System Organ Class: 100000004864

Interventions

Trade Name: Bleomycin "Baxter" Pharmaceutical Form: Powder for infusion INN or Proposed INN: BLEOMYCIN CAS Number: 11056-06-7 Concentration unit: IU international unit(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age > 18 2. Patients should understand participants information 3. Histologically confirmed basal cell carcinoma 4. Signed informed constent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Prior treatment with bleomycin above 200.000 Units/m2 2. Prior radiotherapy to the same area

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate tumorresponse of electrochemotherapy compared with radiotherapy for the treatment of basal cell carcinoma;Secondary Objective: Describe adverse event of electrochemotherapy;Primary end point(s): Evaluate tumorresponse of electhrochemoterapy and standard radiationtherapy and compare the effect of the two treatments;Timepoint(s) of evaluation of this end point: 3 months after end of treatment	—

Measure

Time frame

Main Objective: Evaluate tumorresponse of electrochemotherapy compared with radiotherapy for the treatment of basal cell carcinoma;Secondary Objective: Describe adverse event of electrochemotherapy;Primary end point(s): Evaluate tumorresponse of electhrochemoterapy and standard radiationtherapy and compare the effect of the two treatments;Timepoint(s) of evaluation of this end point: 3 months after end of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Describe adverse events of electrochemotherapy using Common Terminology for Advers Events, version 4.0.;Timepoint(s) of evaluation of this end point: 21 days, 3 months 6 months, 1, 2, and 5 years after end of treatment	—

Countries

Denmark

Contacts

Public ContactDepartment of Oncology, Herlev Hosp

Department of Oncology, Herlev Hospital

camilla.kjaer.loenkvist@regionh.dk004538683868

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026