Basal Cell Carcinoma
Conditions
Keywords
Radiation Therapy, Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT), 20-553
Brief summary
The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence tomography (OCT) device is an effective treatment for basal cell carcinoma (BCC). The researchers will also look at the side effects from RT guided by the RCM/OCT device. In addition, will determine the quality of life before and after treatment by having the participant fill out questionnaires.
Interventions
DEVICEReflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
Patients will undergo RCM/OCT with an imaging specialist in the Dermatology Service. This is not expected to take longer than 30 minutes. Prior to imaging, a digital photograph will be taken of the biopsy proven BCC.
RADIATIONRadiation Therapy
After the completion of skin imaging, patients will undergo simulation and tumor radiotherapy. An equivalent total dose in 2 Gy fractions (EQD2) of 45-46 Gy will be delivered for treatment.
Sponsors
Memorial Sloan Kettering Cancer Center
Physical Sciences Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, open-label, single-center, phase II, single-arm clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven basal cell carcinoma °Up to 3 tumors per patient can be treated per protocol synchronously or metachronously * Clinical stage T1 or T2 by Union International to Control Cancer 8th edition system * ≤40 mm in maximum dimension * no deep invasion (beyond subcutaneous fat or \>6 mm from granular later of dermis to deepest point of carcinoma) * no perineural invasion of nerves ≥0.1 mm diameter or deeper than dermis * no intraneural invasion * no bone erosion, invasion or foraminal transgression NOTE: For the purposes of protocol inclusion, if any of the features mentioned above is not included in the pathology report they will considered absent. * ≥18 years old * Amenable to RCM/OCT and radiation therapy in opinion of investigator * Some anatomic locations may preclude imaging by RCM/OCT may not be amenable to RCM/OCT imaging * Some medical comorbidities may preclude the delivery of radiation therapy (conditions rendering patients hypersensitive to ionizing radiation, or unable to undergo treatment) * Able and willing to complete the Skindex 16 and Skin Cancer Index (must be able to understand English or Spanish)
Exclusion criteria
* Medical contraindication to radiation therapy in the opinion of the investigator * Prior cancer radiotherapy which precludes the ability to safely deliver radiation therapy in the opinion of the investigator * High likelihood of protocol non-compliance in the opinion of the investigator °Patients who demonstrate unwillingness to undergo protocol-defined treatment or follow-up procedures will be ineligible to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histologic tumor response rate | 6 weeks | The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency and severity of adverse events | up to 12 weeks | by the Common Terminology and Criteria for Adverse Events, version 5.0 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Barker, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed