Health TrialsbyHealthPanel

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

ConditionsCutaneous Squamous Cell Carcinoma of the Head and NeckClinically Node-Negative (cN0)High-Risk Cutaneous Squamous Cell Carcinoma (cSCC) of the Head and Neck
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must have histologically and/or biochemically confirmed head and neck cSCC

Location in the ear or the lip,

Diameter greater than 2 cm,

Depth greater than 4 mm,

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sentinel lymph node biopsy (SLNB)

    Procedure/Surgery

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

  • Lymphadenectomy

    Procedure/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 Therapy

    Drug

    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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Sentinel lymph node biopsy (SLNB) + Lymphadenectomy + Adjuvant Definitive TherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Up to 2 years post definitive therapy completion

Secondary outcomes

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

Time frame
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.

Time frame
Up to 2 years post definitive therapy completion
3

Overall survival

Time frame
Up to 2 years post definitive therapy completion
4

Sensitivity of sentinel lymph node biopsy for occult nodal disease

Time frame
Up to 14 days post-SLNB

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now