Clinical trial NCT02131805: Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Official title: A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cutaneous Basal Cell
Squamous Cell Carcinoma
Keywords: skin
Brachytherapy
14-001
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Lynn Cancer Institute
First posted: 2014-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of electronic skin surface brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System. The investigators want to understand what effects, good and/or bad this device for delivering brachytherapy has on your skin cancer. The investigators also want to assess the safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging with clinical response to ESSB.


Eligibility criteria: Inclusion Criteria:

* Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
* Histopathologic diagnosis of basal or squamous cell carcinoma
* Clinical stage T1N0M0 (by AJCC 2010 criteria)

  °Basal cell carcinoma with morpheaform, sclerosing, mixed, infiltrative or micronodular features must be ≤1 cm
* Low risk pathologic features (by AJCC 2010 criteria)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
* Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
* Ability to provide informed consent

Exclusion Criteria:

* BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
* BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
* BCC/SCC on irregular surface (ie, target area not flat)
* BCC/SCC adjacent to or overlapping with burn or scar
* BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
* BCC/SCC in area with compromised lymphatic drainage or vascular supply
* BCC/SCC within 3 cm of another treated or untreated BCC/SCC
* Inflammatory process in target area
* Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
* Diabetes that is poorly controlled
* 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)
* High likelihood of protocol non-compliance (in opinion of investigator)

Primary outcomes:
measure: efficacy of Electronic Skin Surface Brachytherapy (ESSB)
timeFrame: 3 years
measure: assess the cosmetic outcome of ESSB
timeFrame: 3 years
Secondary outcomes:
measure: severity of adverse events
timeFrame: 3 years
measure: reported quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Barker, MD
role: PRINCIPAL_INVESTIGATOR
References: