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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
High Risk Cutaneous Squamous Cell Carcinoma	Procedure: elective lymph node dissection	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	April 2011
Actual Primary Completion Date :	July 14, 2014
Actual Study Completion Date :	July 14, 2014

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. Disease-specific survival [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Overall survival [ Time Frame: 5 years ]
2. Disease-free survival [ Time Frame: 5 years ]
3. Complications [ Time Frame: 5 years ]
   This refers to any adverse event or side effect related to any of the study interventions.
4. quality of life [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	John Zitelli, John A Zitelli, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01252329 History of Changes
Other Study ID Numbers:	PRO10030462
First Posted:	December 2, 2010
Last Update Posted:	October 24, 2017
Last Verified:	October 2017

Keywords provided by John Zitelli, University of Pittsburgh:

high risk cutaneous squamous cell carcinoma; selective neck dissection; elective lymph node management; clinical nodal observation

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell