Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)
|ClinicalTrials.gov Identifier: NCT01252329|
Recruitment Status : Terminated (insufficient recruitment)
First Posted : December 2, 2010
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|High Risk Cutaneous Squamous Cell Carcinoma||Procedure: elective lymph node dissection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Disease-specific survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Disease-free survival [ Time Frame: 5 years ]
- Complications [ Time Frame: 5 years ]This refers to any adverse event or side effect related to any of the study interventions.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252329
|United States, Pennsylvania|
|UPMC Department of Otolaryngology|
|Pittsburgh, Pennsylvania, United States, 15213|
|Zitelli & Brodland PC|
|Pittsburgh, Pennsylvania, United States, 15232|
|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|