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

NCT01252329 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-10-24

No results posted yet for this study

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.

Conditions

  • High Risk Cutaneous Squamous Cell Carcinoma

Interventions

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.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • John A Zitelli, MD · Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

  • David G Brodland, MD · Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

  • Uma Duvvuri, MD,PhD · UPMC Department of Otolaryngology

  • Christine H Weinberger, MD · Zitelli & Brodland PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-07-14
Completion
2014-07-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01252329 on ClinicalTrials.gov