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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by University of Pittsburgh
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01252329
First received: November 30, 2010
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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 Intervention
High Risk Cutaneous Squamous Cell Carcinoma
Procedure: elective lymph node dissection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Disease-specific survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This refers to any adverse event or side effect related to any of the study interventions.

  • quality of life [ Time Frame: 5 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: April 2011
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252329

Contacts
Contact: Christine H Weinberger, MD 4126819400 christine.h.weinberger@gmail.com
Contact: John A Zitelli, MD 4126819400 jazmdpc@aol.com

Locations
United States, Pennsylvania
Zitelli & Brodland PC Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Christine H Weinberger, MD    412-681-9400    christine.h.weinberger@gmail.com   
Contact: John A Zitelli, MD    412-681-9400      
Principal Investigator: John A Zitelli, MD         
Sub-Investigator: Christine H Weinberger, MD         
Sub-Investigator: David G Brodland, MD         
UPMC Department of Otolaryngology Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Uma Duvvuri, MD,PhD    412-647-2100    duvvuriu@upmc.edu   
Principal Investigator: Uma Duvvuri, MD,PhD         
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

No publications provided

Responsible Party: John A. Zitelli, MD, Zitelli & Brodland PC
ClinicalTrials.gov Identifier: NCT01252329     History of Changes
Other Study ID Numbers: PRO10030462
Study First Received: November 30, 2010
Last Updated: April 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on October 01, 2014