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Cutaneous Squamous Cell Carcinoma of the Head and NeckPhase 2NCT06990737

Phase 2 Pragmatic Trial of Sentinel Lymph Node Biopsy (SLNB) in Patients With Clinically Node-Negative (cN0), High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck

A Phase 2 study testing Sentinel lymph node biopsy (SLNB), Lymphadenectomy and Adjuvant Definitive Therapy in people with Cutaneous Squamous Cell Carcinoma of the Head and Neck and Clinically Node-Negative (cN0), run by University of California, Davis.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of SLNB in patients with high-risk cSCC and cN0. The primary goal is to evaluate the efficacy of SLNB based on the DFS rate at 2 years post-definitive therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sentinel lymph node biopsy (SLNB), Lymphadenectomy and Adjuvant Definitive Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
25 Jun 2025to 18 Jun 2026
Phase
Phase 2
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

  • Must have histologically and/or biochemically confirmed head and neck cSCC
  • Must have head and neck cSCC categorized as high risk:
  • Location in the ear or the lip,
  • Diameter greater than 2 cm,
  • Depth greater than 4 mm,
  • Perineural invasion,
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  • Poorly differentiated, and/or
  • Recurrent disease
  • Lymph-node negative (cN0) status confirmed by computed tomography (CT) imaging.
  • Candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC.
  • Zubrod Performance Status 0-2
  • Age ≥18 years at time of consent.
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.

Who cannot join

  • Other active cancers.
  • Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease.
  • Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years.
  • Diagnosis of head and neck mucosal SCC.
  • Prior systemic chemotherapy for head and neck mucosal SCC; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy to the head and neck that would result in overlap of radiation therapy fields.
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  • Patient with severe, active co-morbidity that would preclude a lymphadenectomy.
  • Pregnant or breast-feeding persons.
  • Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Prior surgery for confirmation of tumor pathology is permitted. Note: Borderline suspicious nodes that are ≥1 cm with radiographic finding suggestive of NOT malignant should be biopsied using U/S-guided fine-needle aspirate (FNA) biopsy.
  • Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection).
  • Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte, or immunomodulatory therapy.
  • Currently participating in another investigational therapeutic trial.

About this study

Official title: Phase 2 Pragmatic Trial Investigating Sentinel Lymph Node Biopsy (SLNB) Efficacy and Safety in Patients With Clinically Node-Negative (cN0), High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of SLNB in patients with high-risk cSCC and cN0. The primary goal is to evaluate the efficacy of SLNB based on the DFS rate at 2 years post-definitive therapy.

Read the detailed description

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of SLNB in patients with high-risk cSCC and cN0. Participants must be a candidate for surgical intervention with sentinel lymph node biopsy (SLNB) and potential lymphadenectomy for treatment of cSCC. Following enrollment, participants will have preoperative lymphoscintigraphy performed before planned surgery. During surgery, participants will have SLNs excised from the affected area(s) per standard of care. Surgeon preference will dictate the order of the surgery for resecting the primary tumor. The surgeon may elect to return to the operating room for re-resection of the primary tumor to achieve a negative pathological margin. This may also coincide with a lymphadenectomy if the patient has a positive SLN. Participants will be monitored for adverse events (AEs) during and following their SLNB per institutional practices; only pre-specified AEs of interest will be documented for the study. Definitive systemic therapy (e.g., radiation therapy, chemoradiation therapy) will then be administered per standard of care following surgery.

The primary aim is to evaluate the efficacy of SLNB based on the disease-free survival (DFS) rate at 2 years post-definitive therapy compared to historical control. The patients' 2-year DFS will be analyzed using the Kaplan-Meier approach, and a one-sided log-rank test will be conducted to compare the DFS based on the historical control (50%). Secondary aims include surgical and perioperative morbidity evaluations, and efficacy evaluations assessed by 2-year local/regional control rate, 2-year overall survival, and sensitivity/ specificity of for occult nodal disease.

Being tested
Sentinel lymph node biopsy (SLNB), Lymphadenectomy, Adjuvant Definitive Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentinel lymph node biopsy (SLNB)Procedure or surgery

    Participants will have SLNs excised from the affected area(s) per standard of care

  • LymphadenectomyProcedure or surgery

    Surgeon preference will dictate the order of the surgery for resecting the primary tumor. Elective neck dissection (END) will include nodal basins based on the primary site of disease, at-risk nodal basins, and any additional dissection per the surgeon's discretion. In the event of a positive SLN, the completion neck dissection (CND) should be completed.

  • Adjuvant Definitive TherapyDrug

    Use of chemotherapy will depend on the specific phase of treatment and high-risk features as per standard of care and NCCN Head and Neck Cancer-Clinical Practice Guidelines in Oncology

Study groups in NCT06990737
Study groupRoleWhat they receive
Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive TherapyExperimentalParticipants will have SLNs excised from the affected area(s) per standard of care. Surgeon preference will dictate the order of the surgery for resecting the primary tumor. This may also coincide with a lymphadenectomy if the patient has a positive SLN. Definitive systemic therapy (e.g., radiation therapy, chemoradiation therapy) will then be administered per standard of care following surgery.
Receives: Procedure: Sentinel lymph node biopsy (SLNB); Procedure: Lymphadenectomy; Drug: Adjuvant Definitive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    Defined as the time from definitive therapy to local/regional relapse, distant metastasis, or death due to any cause, whichever comes first.

    Measured: Up to 2 years post definitive therapy completion

Secondary outcomes (5)

  1. Number of participants experiencing surgical and perioperative morbidity

    Assessed per the Clavien-Dindo Classification (CDC) scale 1 and a list of pre-specified complications

    Measured: Through 30 days post-sentinel lymph node biopsy

  2. Local/regional control

    Defined as the time of completing definitive therapy to any evidence of disease in the primary or regional lymph nodes based on biopsy testing or imaging.

    Measured: Up to 2 years post definitive therapy completion

  3. Overall survival

    Measured: Up to 2 years post definitive therapy completion

  4. Sensitivity of sentinel lymph node biopsy for occult nodal disease

    Measured: Up to 14 days post-SLNB

  5. Specificity of sentinel lymph node biopsy for occult nodal disease

    Measured: Up to 14-days post-SLNB

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start25 Jun 2025
  3. Primary completion18 Jun 2026
  4. Study completion18 Jun 2026

Why it stopped: Poor accrual

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06990737
Sponsor's protocol ID
UCDCC319
Other IDs
P30CA093373
Status last verified
Jul 2026
First submitted
16 May 2025
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sentinel lymph node biopsy (SLNB), Lymphadenectomy and Adjuvant Definitive Therapy in people with Cutaneous Squamous Cell Carcinoma of the Head and Neck and Clinically Node-Negative (cN0), run by University of California, Davis.

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 14 inclusion and 12 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: withdrawn, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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-free survival (DFS) (time frame: Up to 2 years post definitive therapy completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06990737.

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 31 Aug 2026.

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