Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
|
| Group 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Brachytherapy (6,1 Gy) | Device | A total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days/week, during 3 weeks or lees, at least 2 days apart each fraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response of Electronic Brachytherapy | Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size). | 2 weeks after treatment |
| Clinical Response of Electronic Brachytherapy | Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size). | 6 weeks after treatment |
| Clinical Response of Electronic Brachytherapy | Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size). | 3 months after treatment |
| Clinical Response of Electronic Brachytherapy | Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size). | 6 months after treatment |
| Clinical Response of Electronic Brachytherapy | Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size). | 12 months after treatment |
| Clinical Response of Electronic Brachytherapy | Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life | Patient quality of life before and after treatment with Esteya Electronic brachytherapy will be measured using the validated Skindex 16 questionnaire. Patient quality of life will be measured before treatment and at 3 months post treatment. | Before treatment and at 3 months post treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2018 | |
| Reset | Mar 21, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2018 | Mar 21, 2018 |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Electronic Brachytherapy (7 Gy) | Device | A total a dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days/week during 3 weeks or lees, at least 2 days apart each fraction. |
|
| 24 months after treatment |
| Rate of grade ≥3-4 adverse events |
The study will use the EORTC-RTOG and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for assessing toxicity related to brachytherapy. Grade 4 or higher adverse events will be reported, with the exception of grade 4 radiation dermatitis. Grade 5 radiation dermatitis will be reported. |
| 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment. |
| Caregiver experience (questionnaire) | User experience with the Esteya electronic brachytherapy device will be measured using the USE Questionnaire (http://hcibib.org/perlman/question.cgi?form=USE). All users of the device will be asked to fill in one questionnaire after their last use of the treatment device. Only one questionnaire will be filled in per user. | 3 weeks |
| D018295 |
| Neoplasms, Basal Cell |