High Risk Cutaneous Squamous Cell Carcinoma
Conditions
Keywords
high risk cutaneous squamous cell carcinoma, selective neck dissection, elective lymph node management, clinical nodal observation
Brief summary
This study will evaluate if there is a difference in survival between elective treatment of draining lymph nodes vs. clinical nodal observation in patients undergoing Mohs surgery for high risk skin squamous cell carcinoma of the head and neck who have a normal lymph node exam. Each treatment arm is accepted as a current standard of care, and the objective is to compare outcomes between the two arms.
Detailed description
This is a prospective, randomized, non-blinded, controlled trial of high risk head and neck cutaneous squamous cell carcinomas which will compare specific outcomes between two treatment arms. Subjects are eligible patients who are sent to Zitelli & Brodland PC for Mohs micrographic surgery of tumors that meet our high risk criteria. These patients with clinically-negative lymph node exams will either enter into the arm of nodal observation or the arm of elective management of the neck, which is currently the standard protocol per the UPMC ENT department. The patients in the observation arm will have evaluation and treatment of their lymph nodes if an abnormality is detected clinically. The primary endpoint is disease-specific survival. Secondary endpoints will include overall and disease-free survival, complications, and quality of life measures for each arm.
Interventions
PROCEDUREelective lymph node dissection
This entails selective lymph node dissection in patients with negative lymph node exams. The nodes dissected are those that drain from the high risk cutaneous squamous cell cancer. Subsequent radiation and/or chemotherapy may be administered in a small percentage of subjects, depending on the result of the neck dissection.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Major criterion and at least one minor criteria * Major criterion: \> 6 mm depth of invasion * Minor criteria (one or more): * Greater than 2cm diameter * Recurrent (prior Mohs, wide local excision, electrodesiccation and curettage, topical imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy) * High risk location: any portion of cutaneous lip, ear, temple, scalp * Immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia) * Perineural invasion (yes/no; nerve involved must be greater than 0.1mm) * Direct involvement of subcutaneous tissue (Clark's V), muscle, cartilage,or bone
Exclusion criteria
* Satellite metastases * Clinically abnormal lymph node exam * Location other than head or neck * Exclusively mucosal squamous cell carcinoma * Previous head and neck radiation * In situ disease, keratoacanthoma subtypes, metatypical or collision tumors * Inability of subject to give written informed consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-specific survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | — |
| Disease-free survival | 5 years | — |
| Complications | 5 years | This refers to any adverse event or side effect related to any of the study interventions. |
| quality of life | 5 years | This refers to quality of life measured with a standard questionnaire. The two arms will be compared with respect to their differences (if any) in quality of life. |
Countries
United States
Outcome results
None listed