Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)

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 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.

Study Overview

• Status: Terminated
• Conditions: High Risk Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: elective lymph node dissection

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Otolaryngology
    • Pittsburgh, Pennsylvania, United States, 15232
      • Zitelli & Brodland PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elective lymph node treatment arm; Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated.	Procedure: elective 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.
No Intervention: Clinical observation arm; Patients who enter into this arm will undergo regular, periodic clinical nodal observation with subsequent evaluation and treatment if indicated upon discovery of a palpable lymph node.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-specific survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		5 years
Disease-free survival		5 years
Complications	This refers to any adverse event or side effect related to any of the study interventions.	5 years
quality of life	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.	5 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: John A Zitelli, MD, Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology; Principal Investigator: David G Brodland, MD, Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology; Principal Investigator: Uma Duvvuri, MD,PhD, UPMC Department of Otolaryngology; Principal Investigator: Christine H Weinberger, MD, Zitelli & Brodland PC

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 14, 2014
• Study Completion (Actual): July 14, 2014

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 21, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: selective neck dissection; high risk cutaneous squamous cell carcinoma; elective lymph node management; clinical nodal observation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: PRO10030462