Clinical trial · Observational
Electronic Brachytherapy for the Treatment of NMSC
Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
- 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)
The objective of this study is to record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the appearance of the treated area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin changes in patients treated for nonmelanoma skin cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| electronic brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-melanoma skin cancer
- description
- Early stage squamous or basal cell carcinoma
- interventionNames
- Radiation: electronic brachytherapy
Primary outcomes (1)
- measure
- Local recurrence of NMSC
- timeFrame
- at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
- description
- Local recurrence
Secondary outcomes (2)
- measure
- Cosmetic outcomes for patients treated for NMSC
- timeFrame
- (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
- description
- Cosmetic outcomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has signed the informed consent form * Pathological diagnosis confirmed of squamous cell or basal cell carcinoma * Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or Gx (Not assessed in report) * Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter) * One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins. Exclusion Criteria: * T2 \> 4 cm and T3 and T4 * American Joint Committee Staging for NMSC Stages III and IV * Histopathologic Grade 3 (poorly differentiated) or higher grade * Target area is adjacent to a burn scar * Target area is on the lip * Patient \< 50 years of age * Any prior definitive surgical resection of the cancer * Perineural invasion * Lesion depth \> 5mm on clinical assessment or as assessed by ultrasound or CT. * Patient is pregnant (pregnancy test required if standard of care). * Target area is prone to trauma. * Target area with compromised lymphatic or vascular drainage. * Participation in another investigational device or drug study concurrently. * Patient has undergone prior radiation therapy to this specific anatomic location. * Patient is receiving pharmacologic agent(s) at or around the time of the Radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study. * Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks after radiation therapy. * Life expectancy less than five (5) years.
References
Publications (1)
- BACKGROUNDBhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non-melanoma skin cancer. Radiat Oncol. 2010 Sep 28;5:87. doi: 10.1186/1748-717X-5-87. PMID 20875139