Nonmelanoma Skin Cancer
Conditions
Brief summary
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.
Detailed description
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up. The study will include 2 parts: 1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC. 2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes.
Interventions
PROCEDUREElectronic Brachytherapy
A group receives High-dose-rate electronic brachytherapy (EBT) which provides a non-surgical treatment option and the other group receives Mohs surgery. This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
Sponsors
Eminence Clinical Research, Inc.
Xoft, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery; 2. Provides informed Consent; 3. Greater than 40 years of age; 4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment; 5. Cancer Staging included in this study: * Stage 0: Tis, N0, M0 * Stage 1: T1, N0, M0 * Stage 2: T2, N0, M0 and ≤ 4cm in diameter
Exclusion criteria
1. Target area is adjacent to a burn scar 2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment 3. Known perineural invasion 4. Actinic Keratosis 5. Known spread to regional lymph nodes 6. Known metastatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS. |
| Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS. |
| Chronic Toxicities | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion. | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS. |
| Patient Survey for Reporting Patient Reported Outcomes (PRO) | Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion. | Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response. |
Countries
United States
Participant flow
Recruitment details
Identify and collect any existing data from the patients record and conduct office visits on patients with non-melanoma skin cancer who underwent treatment with either eBx or Mohs and completed treatment approximately 3 yrs prior (range of 2-4 years) to asses long-term outcomes of treated areas.
Pre-assignment details
N/A This is a retrospective-prospective study design.
Participants by arm
| Arm | Count |
|---|---|
| Electronic Brachytherapy Previously completed treatment of 1 or more non-melanoma skin cancer lesions per participant using Xoft eBx Electronic Brachytherapy System | 188 |
| Electronic Brachytherapy Previously completed treatment of 1 or more non-melanoma skin cancer lesions per participant using Xoft eBx Electronic Brachytherapy System | 208 |
| Mohs Surgery Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery | 181 |
| Mohs Surgery Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery | 208 |
| Total | 785 |
Baseline characteristics
| Characteristic | Mohs Surgery | Total | Electronic Brachytherapy |
|---|---|---|---|
| Age, Customized eBx | 76.6 years STANDARD_DEVIATION 8.8 | 78.7 years STANDARD_DEVIATION 8.3 | 80.8 years STANDARD_DEVIATION 7.2 |
| Lesions by Size Lesions greater than 1cm less than 2cm | 146 lesions | 292 lesions | 146 lesions |
| Lesions by Size Lesions greater than 2cm less than 3cm | 5 lesions | 10 lesions | 5 lesions |
| Lesions by Size Lesions less than 1cm | 57 lesions | 114 lesions | 57 lesions |
| Race/Ethnicity, Customized African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian Non-Hispanic | 180 Participants | 366 Participants | 186 Participants |
| Sex/Gender, Customized Female | 61 Participants | 126 Participants | 65 Participants |
| Sex/Gender, Customized Male | 120 Participants | 243 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 188 |
| other Total, other adverse events | 79 / 181 | 107 / 188 |
| serious Total, serious adverse events | 0 / 181 | 0 / 188 |
Outcome results
Primary
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electronic Brachytherapy | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Participants Analyzed | 188 participants |
| Electronic Brachytherapy | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Absence of Local Recurrence | 187 participants |
| Electronic Brachytherapy | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Lesions Analyzed | 208 participants |
| Mohs Surgery | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Participants Analyzed | 181 participants |
| Mohs Surgery | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Absence of Local Recurrence | 181 participants |
| Mohs Surgery | Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up | Lesions Analyzed | 208 participants |
Secondary
Chronic Toxicities
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
Population: Analysis same as late toxicities.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Electronic Brachytherapy | Chronic Toxicities | 138 Lesions Analyzed |
| Mohs Surgery | Chronic Toxicities | 143 Lesions Analyzed |
Secondary
Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Brachytherapy | Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit | 138 lesions |
| Mohs Surgery | Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit | 143 lesions |
Secondary
Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Brachytherapy | Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs | 203 lesions |
| Mohs Surgery | Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs | 199 lesions |
Secondary
Patient Survey for Reporting Patient Reported Outcomes (PRO)
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Brachytherapy | Patient Survey for Reporting Patient Reported Outcomes (PRO) | 54.0 score on a scale | Standard Deviation 9 |
| Mohs Surgery | Patient Survey for Reporting Patient Reported Outcomes (PRO) | 56.0 score on a scale | Standard Deviation 5.3 |