Clinical trial · Interventional
Comparison of Elective Lymph Node Treatment Versus Clinical Observation in the Absence of Palpable Lymph Nodes for High Risk Skin Squamous Cell Carcinoma (SCC)
High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs. Periodic Clinical Nodal Observation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Cutaneous Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| elective lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Elective lymph node treatment arm
- description
- Patients entering this arm will undergo selective nodal dissection of the draining lymph nodes with subsequent radiation and/or chemotherapy if indicated.
- interventionNames
- Procedure: elective lymph node dissection
- type
- NO_INTERVENTION
- label
- Clinical observation 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.
Primary outcomes (1)
- measure
- Disease-specific survival
- timeFrame
- 5 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available