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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252329
Recruitment Status : Terminated (insufficient recruitment)
First Posted : December 2, 2010
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):
John Zitelli, University of Pittsburgh

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 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

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.

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.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252329

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
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

Responsible Party: John Zitelli, John A Zitelli, MD, University of Pittsburgh Identifier: NCT01252329     History of Changes
Other Study ID Numbers: PRO10030462
First Posted: December 2, 2010    Key Record Dates
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, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell