MedDataX Logo

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

NCT ID: NCT01252329

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-07-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High Risk Cutaneous Squamous Cell Carcinoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

high risk cutaneous squamous cell carcinoma selective neck dissection elective lymph node management clinical nodal observation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

elective lymph node dissection

Intervention Type PROCEDURE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Zitelli

John A Zitelli, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John A Zitelli, MD

Role: PRINCIPAL_INVESTIGATOR

Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

David G Brodland, MD

Role: PRINCIPAL_INVESTIGATOR

Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

Uma Duvvuri, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

UPMC Department of Otolaryngology

Christine H Weinberger, MD

Role: PRINCIPAL_INVESTIGATOR

Zitelli & Brodland PC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UPMC Department of Otolaryngology

Pittsburgh, Pennsylvania, United States

Site Status

Zitelli & Brodland PC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO10030462

Identifier Type: -

Identifier Source: org_study_id