Clinical trial NCT01252329: Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)
Official title: High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs. Periodic Clinical Nodal Observation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: High Risk Cutaneous Squamous Cell Carcinoma
Keywords: high risk cutaneous squamous cell carcinoma
selective neck dissection
elective lymph node management
clinical nodal observation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-specific survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Disease-free survival
timeFrame: 5 years
measure: Complications
timeFrame: 5 years
measure: quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Department of Otolaryngology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Zitelli & Brodland PC
state: Pennsylvania
Study officials:
affiliation: Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology
name: John A Zitelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology
name: David G Brodland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPMC Department of Otolaryngology
name: Uma Duvvuri, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zitelli & Brodland PC
name: Christine H Weinberger, MD
role: PRINCIPAL_INVESTIGATOR
References: