High Risk Cutaneous Squamous Cell CarcinomaNCT01252329
Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)
A study testing elective lymph node dissection in people with High Risk Cutaneous Squamous Cell Carcinoma, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Cutaneous Squamous Cell Carcinoma
- What is being tested?
- elective lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to 14 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Department of Otolaryngology
Pittsburgh, Pennsylvania, 15213
Zitelli & Brodland PC
Pittsburgh, Pennsylvania, 15232
About this study
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
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.
Read the 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.
- Being tested
- elective lymph node dissection
- Keywords
- high risk cutaneous squamous cell carcinoma, selective neck dissection, elective lymph node management, clinical nodal observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective lymph node dissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Elective lymph node treatment arm | Active comparator | Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated. Receives: Procedure: elective lymph node dissection |
| Clinical observation arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific survival
Measured: 5 years
Secondary outcomes (4)
Overall survival
Measured: 5 years
Disease-free survival
Measured: 5 years
Complications
This refers to any adverse event or side effect related to any of the study interventions.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startApr 2011
- Primary completion14 Jul 2014
- Study completion14 Jul 2014
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Zitelli, University of Pittsburgh
- Investigators
- John A Zitelli, MD, Principal investigator, Zitelli & Brodland PC; UPMC Departments of Dermatology and OtolaryngologyDavid G Brodland, MD, Principal investigator, Zitelli & Brodland PC; UPMC Departments of Dermatology and OtolaryngologyUma Duvvuri, MD,PhD, Principal investigator, UPMC Department of OtolaryngologyChristine H Weinberger, MD, Principal investigator, Zitelli & Brodland PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252329
- Sponsor's protocol ID
- PRO10030462
- Status last verified
- Oct 2017
- First submitted
- 30 Nov 2010
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01252329
- Acronym / sponsor ID
- PRO10030462
- Keywords
- high risk cutaneous squamous cell carcinoma, selective neck dissection, elective lymph node management, clinical nodal observation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- 14 Jul 2014 (actual)
- Study completion
- 14 Jul 2014 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective lymph node treatment arm | Active comparator | Procedure: elective lymph node dissectionPatients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated. |
| Clinical observation arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Satellite metastases
- Clinically abnormal lymph node exam
- Location other than head or neck
- Exclusively mucosal squamous cell carcinoma
- Previous head and neck radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elective lymph node dissectionThis 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. | Procedure or surgery | Elective lymph node treatment arm |
Primary outcome
Disease-specific survival
Time frame: 5 years
4 secondary outcomes
Overall survival
Time frame: 5 years
Disease-free survival
Time frame: 5 years
Complications
Time frame: 5 years
quality of life
Time frame: 5 years
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Zitelli, MD principal investigator
Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology
David G Brodland, MD principal investigator
Zitelli & Brodland PC; UPMC Departments of Dermatology and Otolaryngology
Uma Duvvuri, MD,PhD principal investigator
UPMC Department of Otolaryngology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elective lymph node dissection in people with High Risk Cutaneous Squamous Cell Carcinoma, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-specific survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.