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New treatment option for Cutaneous Squamous Cell Carcinoma of the Head and Neck
Official title 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
ClinicalTrials.gov ID: NCT06990737
What this study is testing
What is Adjuvant Definitive Therapy?
Adjuvant Definitive Therapy is an investigational medicine, being studied as a potential treatment for cutaneous squamous cell carcinoma of the head and neck.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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,
- 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.
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.