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 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01252329
• Other study ID #: PRO10030462
• Status: Terminated
• Phase: N/A
• First received: November 30, 2010
• Last updated: October 21, 2017
• Start date: April 2011
• Est. completion date: July 14, 2014

Study information

• Verified date: October 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: July 14, 2014
• Est. primary completion date: July 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• High Risk Cutaneous Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Department of Otolaryngology	Pittsburgh	Pennsylvania
United States	Zitelli & Brodland PC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-specific survival		5 years
Secondary	Overall survival		5 years
Secondary	Disease-free survival		5 years
Secondary	Complications	This refers to any adverse event or side effect related to any of the study interventions.	5 years
Secondary	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