Overview
Sponsor-declared trial summary
Basal cell carcinoma (non-melanoma skin cancer)
To compare effect of electhrochemotherapy versus standard radiotherapy for the treatment of basal cell carcinomas less than 3 cm.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 16 Nov 2020 → ongoing
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519066-49-01
- EudraCT number
- 2016-002255-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare effect of electhrochemotherapy versus standard radiotherapy for the treatment of basal cell carcinomas less than 3 cm.
Secondary objectives 3
- Adverse events
- Cosmesis
- Patient satisfaction
Conditions and MedDRA coding
Basal cell carcinoma (non-melanoma skin cancer)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10004146 | Basal cell carcinoma | 100000004864 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- The plan is to share data with the International Network for Sharing Practices on Electrochemotherapy (InspECT) database.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519066-49-00 | Electrochemotherapy versus standard radiotherapy for the treatment of basal cell carcinoma | Region Hovedstaden |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age above 18 years
- Biopsy verified basal cell carcinoma under 3 cm accessible for both radiotherapy and elechtrochemoterapy
- Subject must understand patient information
- Signed informed consent
Exclusion criteria 5
- Metastatic basal cell carcinoma
- Previous treatment with bleomycin above 200.000 Units/m2
- Previous severe allergic reactions to bleomycin
- Pregnancy or breast feeding
- Participation in other trials with trial medication
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Effect of electhrochemotherapy versus standard radiotherapy for the treatment of basal cell carcinomas less than 3 cm.
Secondary endpoints 3
- Adverse events
- Cosmesis
- Patient satisfaction
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Bleomycin ”Baxter”, pulver til injektions- og infusionsvæske, opløsning
PRD345428 · Product
- Active substance
- Bleomycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRATUMORAL
- Max daily dose
- 9000 IU international unit(s)
- Max total dose
- 9000 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- 05689
- MA holder
- BAXTER A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Borgmester Ib Juuls Vej 31
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Department of Oncology
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Department of Oncology
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 52 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2020-11-16 | 2021-04-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-519066-49-01_redacted | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements blank | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_DK | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_DK_redacted | 3.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC bleomycin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-03 | Denmark | Acceptable 2024-12-16
|
2024-12-16 |