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High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs. Periodic Clinical Nodal Observation


N/A
18 Years
N/A
Open (Enrolling)
Both
High Risk Cutaneous Squamous Cell Carcinoma

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Trial Information

High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs. Periodic Clinical Nodal Observation


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-specific survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

John A Zitelli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

Authority:

United States: Institutional Review Board

Study ID:

PRO10030462

NCT ID:

NCT01252329

Start Date:

April 2011

Completion Date:

May 2022

Related Keywords:

  • High Risk Cutaneous Squamous Cell Carcinoma
  • high risk cutaneous squamous cell carcinoma
  • selective neck dissection
  • elective lymph node management
  • clinical nodal observation
  • Carcinoma
  • Carcinoma, Squamous Cell

Name

Location
Zitelli & Brodland PC Pittsburgh, Pennsylvania  15232
UPMC Department of Otolaryngology Pittsburgh, Pennsylvania  15213