Status:
TERMINATED
Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)
Lead Sponsor:
University of Pittsburgh
Conditions:
High Risk Cutaneous Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01252329
Start Date
April 1 2011
End Date
July 14 2014
Last Update
October 24 2017
Active Locations (2)
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1
UPMC Department of Otolaryngology
Pittsburgh, Pennsylvania, United States, 15213
2
Zitelli & Brodland PC
Pittsburgh, Pennsylvania, United States, 15232