Back to results

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

Primary Purpose

High Risk Cutaneous Squamous Cell Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

elective lymph node dissection

About this trial

This is an interventional treatment trial for High Risk Cutaneous Squamous Cell Carcinoma focused on measuring high risk cutaneous squamous cell carcinoma, selective neck dissection, elective lymph node management, clinical nodal observation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UPMC Department of Otolaryngology
Zitelli & Brodland PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Elective lymph node treatment arm

Clinical observation arm

Arm Description

Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated.

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.

Outcomes

Primary Outcome Measures

Disease-specific survival

Secondary Outcome Measures

Overall survival

Disease-free survival

Complications

This refers to any adverse event or side effect related to any of the study interventions.

quality of life

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.

Full Information

NCT ID

NCT01252329

First Posted

November 30, 2010

Last Updated

October 21, 2017

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT01252329

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

insufficient recruitment

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 14, 2014 (Actual)

Study Completion Date

July 14, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Risk Cutaneous Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elective lymph node treatment arm

Arm Type

Active Comparator

Arm Description

Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated.

Arm Title

Clinical observation arm

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

elective lymph node dissection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease-specific survival

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

5 years

Title

Disease-free survival

Time Frame

5 years

Title

Complications

Description

This refers to any adverse event or side effect related to any of the study interventions.

Time Frame

5 years

Title

quality of life

Description

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.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John A Zitelli, MD

Organizational Affiliation

Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David G Brodland, MD

Organizational Affiliation

Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Uma Duvvuri, MD,PhD

Organizational Affiliation

UPMC Department of Otolaryngology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christine H Weinberger, MD

Organizational Affiliation

Zitelli & Brodland PC

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Department of Otolaryngology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Zitelli & Brodland PC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs