Clinical trial · Interventional
Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment. The objective of ths study will be to determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Brachytherapy (6,1 Gy) | Device | — | UNRESOLVED |
| Electronic Brachytherapy (7 Gy) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- For the first 20 patients, a total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days week, 3 weeks or lees at least 2 days apart each fraction.
- interventionNames
- Device: Electronic Brachytherapy (6,1 Gy)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- For the next 20 patients a total dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days week 3 weeks or lees at least 2 days apart each fraction.
- interventionNames
- Device: Electronic Brachytherapy (7 Gy)
Primary outcomes (6)
- measure
- Clinical Response of Electronic Brachytherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women ≥18 years old. * Estimated life expectancy of ≥5 years * Histopathologic diagnosis of early and primary Basal Cell Carcinoma (BCC) * Clinical stage of BCC: T1 or T2 (by AJCC 2010 criteria, see Table 1) * Histological subtypes: Superficial BCC or nodular BCC * Maximum diameter of lesion: 20 mm * Maximum depth of invasion: 4 mm. * Ability to provide informed consent * Punch biopsy of primary tumor to depth of reticular dermis Exclusion Criteria: * Men or women \<18 years old. * Estimated life expectancy \<5 years. * BCC that was previously treated (ie, recurrent BCC) * BCC in region adjacent to or overlapping with region of prior radiotherapy * BCC on irregular surface (ie, target area not flat) * BCC adjacent to or overlapping with burn or scar * BCC in area prone to trauma * BCC in area with compromised lymphatic drainage or vascular supply * Inflammatory process in target area * Pregnancy or lactation * Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis) * Diabetes that is poorly controlled (Hg A1c \>7%) * Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans) * Receipt of treatment with another investigational device or drug * Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector) * Receipt or plan to receive chemotherapy within 6 weeks of radiation therapy * High likelihood of protocol non-compliance (in opinion of investigator)
References
Publications (0)
Data not yet available